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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
HDO
Valve, Tubal Occlusion
3
Product Code
HDR
Cap, Cervical
2
Product Code
HDT
Device, Intrauterine, Contraceptive And Introducer
3
Product Code
HDW
Diaphragm, Contraceptive (And Accessories)
2
Product Code
HEB
Tampon, Menstrual, Unscented
2
Product Code
HEC
Insufflator, Vaginal
1
Product Code
HED
Douche Apparatus, Vaginal, Therapeutic
1
Product Code
HEE
Set, Anesthesia, Paracervical
2
Product Code
HEG
Set, Anesthesia, Pudendal
2
Product Code
HEH
Chamber, Decompression, Abdominal
3
Product Code
HFY
Band, Tubal Occlusion
3
Product Code
HGB
Clip, Tubal Occlusion
3
Product Code
HGF
Source, Abortion Unit, Vacuum
2
Product Code
HGG
Controller, Abortion Unit, Vacuum
2
Product Code
HGH
Cannula, Suction, Uterine
2
Product Code
HGX
Pump, Breast, Powered
2
Product Code
K
24
0218
Electric Breast Pump (F5055)
2
Cleared 510(K)
K
24
2125
Elvie Stride 2
2
Cleared 510(K)
K
24
1004
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
2
Cleared 510(K)
K
23
1969
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
2
Cleared 510(K)
K
24
1705
MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)
2
Cleared 510(K)
K
24
0536
Wearable Breast Pump (Model S32)
2
Cleared 510(K)
K
24
1506
Annabella Double Breast Pump (ADO-US23-1000)
2
Cleared 510(K)
K
23
2774
Wearable Breast Pump,Model S18
2
Cleared 510(K)
K
23
3913
Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
2
Cleared 510(K)
K
23
2477
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
2
Cleared 510(K)
K
23
2608
Duo Hands-free Breast Pump
2
Cleared 510(K)
K
23
2047
VIVACE
2
Cleared 510(K)
K
23
3136
Hygeia Express Powered Breast Pump
2
Cleared 510(K)
K
23
3880
Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
2
Cleared 510(K)
K
23
1785
Perifit Pump
2
Cleared 510(K)
K
23
2466
Electric Breast Pump, model: YM-8166
2
Cleared 510(K)
K
23
0481
Evenflo Premium Double Electric Breast Pump (Model 4018)
2
Cleared 510(K)
K
23
1595
Electric Breast Pump
2
Cleared 510(K)
K
23
0570
Willow Generation 3 Breast Pump
2
Cleared 510(K)
K
23
0102
Smart double sides wearable breast pump, Electric bilateral breast pump
2
Cleared 510(K)
K
23
0672
Annabella Breast Pump
2
Cleared 510(K)
K
22
3886
Wearable Breast Pump (Model S18)
2
Cleared 510(K)
K
23
0469
Compact Wearable Pump
2
Cleared 510(K)
K
23
0776
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
2
Cleared 510(K)
K
22
3329
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
2
Cleared 510(K)
K
23
0590
ARDO Bellis
2
Cleared 510(K)
K
22
3084
MilkMate Breast Pump
2
Cleared 510(K)
K
22
3693
Electric breast pump (model: M5)
2
Cleared 510(K)
K
22
2573
imani i2Plus Breast Pump
2
Cleared 510(K)
K
22
2782
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
2
Cleared 510(K)
K
22
2045
Wearable Breast Pump (Model S1DW)
2
Cleared 510(K)
K
22
2726
Smartpump 3.0 Double Electric Breast Pump
2
Cleared 510(K)
K
22
1708
CIMILRE Free-T2 Plus
2
Cleared 510(K)
K
22
0926
Spectra Wearable
2
Cleared 510(K)
K
22
1598
Wearable breast pump
2
Cleared 510(K)
K
22
1576
Ameda Pearl Electric Breast Pump
2
Cleared 510(K)
K
21
1016
Powered Breast Pump (Models 7V and 7X)
2
Cleared 510(K)
K
22
0309
Wearable Breast Pump (Model S10)
2
Cleared 510(K)
K
22
0596
Wearable Breast Pump (Model S9)
2
Cleared 510(K)
K
21
2564
Electric Breast Pump
2
Cleared 510(K)
K
21
2773
ARDO Alyssa
2
Cleared 510(K)
K
21
2955
Fit Pro Breast Pump
2
Cleared 510(K)
K
21
2180
Wearable Breast Pump (Model S12)
2
Cleared 510(K)
K
21
1024
Electric Breast Pump
2
Cleared 510(K)
K
21
3311
Lucy Breast Pump
2
Cleared 510(K)
K
21
2884
Electric breast pump
2
Cleared 510(K)
K
21
1755
Electric Breast Pump
2
Cleared 510(K)
K
21
0124
Synergy Gold (SG) Portable (Models MM011450 and MM011460)
2
Cleared 510(K)
K
20
2802
TT Electric Breast Pump, TT Double Electric Breast Pump
2
Cleared 510(K)
K
21
0936
Elvie Stride
2
Cleared 510(K)
K
21
0759
Solo, Swing Maxi
2
Cleared 510(K)
K
20
3148
Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
2
Cleared 510(K)
K
20
1152
Electric Breast Pump
2
Cleared 510(K)
K
20
3570
Mya Joy PLUS Breast Pump
2
Cleared 510(K)
K
20
1903
Electric breast pump (Models: RH-228 and RH-338)
2
Cleared 510(K)
K
20
2037
imani i2
2
Cleared 510(K)
K
20
2045
imani i1
2
Cleared 510(K)
K
20
0675
Hi bebe super (Models BT-150S and BT-150L)
2
Cleared 510(K)
K
20
3383
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
2
Cleared 510(K)
K
20
1381
Philips Avent Single/Double electric breast pump Advanced
2
Cleared 510(K)
K
19
3449
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
2
Cleared 510(K)
K
20
0508
Pump In Style
2
Cleared 510(K)
K
20
0712
Rumble Tuff Electric Breast Pump
2
Cleared 510(K)
K
19
2640
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
2
Cleared 510(K)
K
20
0406
Evolve Breast Pump
2
Cleared 510(K)
K
19
1109
Spectra Q
2
Cleared 510(K)
K
19
1802
Electric Breast Pump
2
Cleared 510(K)
K
19
0465
Evolve Breast Pump
2
Cleared 510(K)
K
19
1653
Freestyle Flex
2
Cleared 510(K)
K
19
1208
Spectra Cashmere
2
Cleared 510(K)
K
19
1577
Willow Wearable Breast Pump 2.0
2
Cleared 510(K)
K
19
0810
OPERA, OPERA eco
2
Cleared 510(K)
K
18
2749
Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
2
Cleared 510(K)
K
18
2413
Electric Breast Pump
2
Cleared 510(K)
K
18
1784
Spectra S3 Plus
2
Cleared 510(K)
K
18
1937
Pump In Style Advanced, Advanced Personal Double Breastpump
2
Cleared 510(K)
K
18
1863
Elvie Pump
2
Cleared 510(K)
K
18
0075
MINUET LCD, MINUET LCD eco
2
Cleared 510(K)
K
17
2842
GCE704 Breast Pump
2
Cleared 510(K)
K
17
3699
The Pump by Babyation
2
Cleared 510(K)
K
17
2989
Electric Breast Pump
2
Cleared 510(K)
K
17
2067
One Mum Pumpset
2
Cleared 510(K)
K
17
2772
Freemie Independence, Freemie Liberty
2
Cleared 510(K)
K
16
3183
Yooeehouse Breast Pump
2
Cleared 510(K)
K
17
0722
Moxxly Flow Collection System
2
Cleared 510(K)
K
16
3136
Youha electric breast pump
2
Cleared 510(K)
K
16
2415
Spectra 9Plus
2
Cleared 510(K)
K
16
2870
CIMLRE F1 and CIMILRE S3
2
Cleared 510(K)
K
16
2747
Proture Double Electric Breast Pump
2
Cleared 510(K)
K
16
1725
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
2
Cleared 510(K)
K
16
0274
Hi bebe plus
2
Cleared 510(K)
K
16
1532
Philips Avent Comfort Single/Twin Electric Breast Pump
2
Cleared 510(K)
K
16
1266
Athena Breast Pump
2
Cleared 510(K)
K
16
0511
Naya Breast Pump System
2
Cleared 510(K)
K
15
0476
Spectra S1Plus and Spectra S2 Plus
2
Cleared 510(K)
K
15
1284
Electric Double Breast Pumps
2
Cleared 510(K)
K
15
0923
Breast Pump
2
Cleared 510(K)
K
15
1632
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
2
Cleared 510(K)
K
15
0721
ARDO Calypso Pro Powered Breast Pump
2
Cleared 510(K)
K
14
3585
Electric Breast Pump
2
Cleared 510(K)
K
15
0499
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
2
Cleared 510(K)
K
14
3574
Melodi Prime Breast Pump
2
Cleared 510(K)
K
14
2479
MEGNA BREAST PUMPS
2
Cleared 510(K)
K
13
2220
PJ'S SERENITY
2
Cleared 510(K)
K
14
2168
NATURE'S BOND 600 AND NATURE'S BOND 603
2
Cleared 510(K)
K
14
1742
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
2
Cleared 510(K)
K
13
2882
ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
13
0349
FREEMIE BREAST COLLECTION SYSTEM
2
Cleared 510(K)
K
13
1153
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
13
1027
MEMORY PUMP MODEL Y4947
2
Cleared 510(K)
K
12
1478
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
12
2474
LANSINOH POWERED ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
11
3315
RUMBLE TUFF
2
Cleared 510(K)
K
12
1322
CLOSER TO NATURE
2
Cleared 510(K)
K
11
2856
LUCINA-MELODI
2
Cleared 510(K)
K
11
3664
CLOSER TO NATURE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
11
1411
FREEMIE (R)
2
Cleared 510(K)
K
10
2516
LUCINA MODEL MELODI
2
Cleared 510(K)
K
11
0343
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
10
2600
SIMPLYGO BREAST PUMP
2
Cleared 510(K)
K
10
1157
E-BASIC SINGLE BREAST PUMP
2
Cleared 510(K)
K
09
3145
SPECTRA SERIES BREAST PUMP
2
Cleared 510(K)
K
09
3648
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
2
Cleared 510(K)
K
10
0929
UNIMOM ALLEGRO
2
Cleared 510(K)
K
10
0435
AMEDA PLATINUM BREAST PUMP
2
Cleared 510(K)
K
10
0385
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
09
2783
DEBP
2
Cleared 510(K)
K
09
2770
SIMPLYGO HANDS FREE BREAST PUMP
2
Cleared 510(K)
K
08
1463
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
2
Cleared 510(K)
K
08
1932
ENDEARE BREAST PUMP
2
Cleared 510(K)
K
08
2802
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
2
Cleared 510(K)
K
08
2307
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
2
Cleared 510(K)
K
07
0435
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
2
Cleared 510(K)
K
06
1013
PLAYTEX EMBRACE PETITE BREAST PUMP
2
Cleared 510(K)
K
05
3052
MEDELA SWING BREAST PUMP
2
Cleared 510(K)
K
05
1926
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
05
2909
EVENFLO ELAN BREAST PUMP
2
Cleared 510(K)
K
05
2047
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
2
Cleared 510(K)
K
05
1112
WHITTLESTONE EXPRESSER
2
Cleared 510(K)
K
05
1413
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
2
Cleared 510(K)
K
04
3098
GERBER DOUBLE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
03
3131
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
2
Cleared 510(K)
K
03
2566
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
03
1614
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
2
Cleared 510(K)
K
02
1739
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
2
Cleared 510(K)
K
02
2933
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
2
Cleared 510(K)
K
02
2594
PLAYTEX BREAST PUMP
2
Cleared 510(K)
K
02
2140
WHISPER WEAR BREAST PUMP
2
Cleared 510(K)
K
02
0375
THE NURTURE III BREAST PUMP
2
Cleared 510(K)
K
02
0518
MEDELA SYMPHONY BREAST PUMP, MODEL 024
2
Cleared 510(K)
K
01
2275
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
00
2696
WHITTLESTONE BREASTPUMP
2
Cleared 510(K)
K
98
1549
LACTATION TECHNIQUES MODEL B
2
Cleared 510(K)
K
98
3776
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
2
Cleared 510(K)
K
97
3501
EXPRESSE AND PREMIER POWERED BREAST PUMPS
2
Cleared 510(K)
K
97
0488
HYDROCHECK MICRO FILTER
2
Cleared 510(K)
K
97
1543
LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
96
4679
WHITE RIVER AUTOMATIC BREAST PUMP
2
Cleared 510(K)
K
96
4396
DOUBLE UP BREAST PUMP
2
Cleared 510(K)
K
96
0727
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
2
Cleared 510(K)
K
96
4403
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
2
Cleared 510(K)
K
96
0726
EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
2
Cleared 510(K)
K
95
2712
WHITE RIVER BATTERY-POWERED BREAST PUMP
2
Cleared 510(K)
K
95
0750
MEDELAS BREAST PUMP
2
Cleared 510(K)
K
95
0531
EGNELL ELITE
2
Cleared 510(K)
K
94
2534
GERBER NATURAL COMFORT BATTERY BREAST PUMP
2
Cleared 510(K)
K
92
4312
NURTURE III
2
Cleared 510(K)
K
94
1112
SINGLE HANDED BREAST PUMP
2
Cleared 510(K)
K
93
6309
DELUXE MAGMAG BREAST PUMP
2
Cleared 510(K)
K
93
5249
ADVANCED MAGMAG AC/BATTERY BREAST PUMP
2
Cleared 510(K)
K
92
1261
ELECTRIC POWERED BREAST PUMP
2
Cleared 510(K)
K
90
1344
MEDELA BATTERY OPERATED BREAST PUMP
2
Cleared 510(K)
K
89
5114
FRANK MILK PUMP
2
Cleared 510(K)
K
89
3545
IVEX MODEL NO. BP 3000 BREASTPUMP
2
Cleared 510(K)
K
89
1996
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
89
0588
GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
87
5300
MEDELA BREAST-PUMP LACTINA
2
Cleared 510(K)
K
87
4071
MOTHER'S MILK BAG
2
Cleared 510(K)
K
86
1513
LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP
2
Cleared 510(K)
K
85
3326
WATER DRIVEN BREAST PUMP BY BABY NURSE
2
Cleared 510(K)
K
85
3107
AXICARE CM-14 AUTOMATIC BREAST PUMP
2
Cleared 510(K)
K
85
2460
GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
2
Cleared 510(K)
K
85
0705
THE WHITE RIVER PORTA-ELEC-BREAST PUMP
2
Cleared 510(K)
K
85
0753
NATURAL MOTHER BREAST PUMP
2
Cleared 510(K)
K
84
4013
CARE ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
84
4307
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
2
Cleared 510(K)
K
84
2766
CRYSTAL MEDICAL MILK COLLECTION KIT
2
Cleared 510(K)
K
81
1403
AXICARE BREAST PUMP MODEL
2
Cleared 510(K)
K
81
0065
SCOTT CM42 PASTEURIZER
2
Cleared 510(K)
K
80
1862
MEDELA ELECTRIC BREAST PUMP
2
Cleared 510(K)
K
80
1246
OXFORD HUMAN MILK PASTEURISER
2
Cleared 510(K)
HGY
Pump, Breast, Non-Powered
1
Product Code
HGZ
Heater, Perineal, Direct Contact
2
Product Code
HHA
Heater, Perineal, Radiant, Non-Contact
2
Product Code
HHD
Pad, Menstrual, Unscented
1
Product Code
HHE
Cup, Menstrual
2
Product Code
HHI
System, Abortion, Vacuum
2
Product Code
HHL
Pad, Menstrual, Scented
2
Product Code
HHQ
System, Abortion, Metreurynter-Balloon
3
Product Code
HHS
Transcervical Contraceptive Tubal Occlusion Device
3
Product Code
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
3
Product Code
HIL
Tampon, Menstrual, Scented, Deodorized
2
Product Code
HIS
Condom
2
Product Code
KND
Heater, Perineal
2
Product Code
KNE
Set, Anesthesia, Obstetric
2
Product Code
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
3
Product Code
KXQ
Vibrator For Therapeutic Use, Genital
2
Product Code
LTZ
Condom With Nonoxynol-9
2
Product Code
LZL
Micro-Condom
3
Product Code
MBU
Single-Use Internal Condom
2
Product Code
MFD
Cannula, Intrauterine Insemination
2
Product Code
NUR
Pad, Interlabial
1
Product Code
MOL
Condom, Synthetic
2
Product Code
MSC
Barrier, Std, Oral Sex
2
Product Code
NBV
Device, Engorgement, Clitoral
2
Product Code
NRC
Pads, Menstrual, Scented-Deodorized
1
Product Code
NUC
Lubricant, Personal
2
Product Code
NUQ
Pad, Menstrual, Reusable
1
Product Code
OBB
Kit, Conception-Assist, Home Use
2
Product Code
OBY
Condom, Female, Animal Tissue
3
Product Code
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
2
Product Code
OHH
Breast Pump Kit
2
Product Code
OKW
Seminal Fluid Collection Kit
2
Product Code
OOA
Hemorrhoid Prevention Pressure Wedge
2
Product Code
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
2
Product Code
PVT
Maternity Kit
1
Product Code
PVU
Obstetrical Anesthesia Kit
2
Product Code
PVV
Paracervical Anesthesia Kit
2
Product Code
PVW
Pudendal Anesthesia Kit
2
Product Code
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
1
Product Code
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
2
Product Code
QPD
Personal Lubricant Ring
2
Product Code
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 13 December 2024 at 11:05 pm
OB
/
subpart-f—obstetrical-and-gynecological-therapeutic-devices
/
HGX
/
K053052
View Source
MEDELA SWING BREAST PUMP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053052
510(k) Type
Traditional
Applicant
MEDELA AG
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
5/2/2006
Days to Decision
183 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
HDO
Valve, Tubal Occlusion
HDR
Cap, Cervical
HDT
Device, Intrauterine, Contraceptive And Introducer
HDW
Diaphragm, Contraceptive (And Accessories)
HEB
Tampon, Menstrual, Unscented
HEC
Insufflator, Vaginal
HED
Douche Apparatus, Vaginal, Therapeutic
HEE
Set, Anesthesia, Paracervical
HEG
Set, Anesthesia, Pudendal
HEH
Chamber, Decompression, Abdominal
HFY
Band, Tubal Occlusion
HGB
Clip, Tubal Occlusion
HGF
Source, Abortion Unit, Vacuum
HGG
Controller, Abortion Unit, Vacuum
HGH
Cannula, Suction, Uterine
HGX
Pump, Breast, Powered
K
24
0218
Electric Breast Pump (F5055)
K
24
2125
Elvie Stride 2
K
24
1004
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
K
23
1969
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
K
24
1705
MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)
K
24
0536
Wearable Breast Pump (Model S32)
K
24
1506
Annabella Double Breast Pump (ADO-US23-1000)
K
23
2774
Wearable Breast Pump,Model S18
K
23
3913
Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
K
23
2477
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
K
23
2608
Duo Hands-free Breast Pump
K
23
2047
VIVACE
K
23
3136
Hygeia Express Powered Breast Pump
K
23
3880
Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
K
23
1785
Perifit Pump
K
23
2466
Electric Breast Pump, model: YM-8166
K
23
0481
Evenflo Premium Double Electric Breast Pump (Model 4018)
K
23
1595
Electric Breast Pump
K
23
0570
Willow Generation 3 Breast Pump
K
23
0102
Smart double sides wearable breast pump, Electric bilateral breast pump
K
23
0672
Annabella Breast Pump
K
22
3886
Wearable Breast Pump (Model S18)
K
23
0469
Compact Wearable Pump
K
23
0776
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
K
22
3329
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
K
23
0590
ARDO Bellis
K
22
3084
MilkMate Breast Pump
K
22
3693
Electric breast pump (model: M5)
K
22
2573
imani i2Plus Breast Pump
K
22
2782
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
K
22
2045
Wearable Breast Pump (Model S1DW)
K
22
2726
Smartpump 3.0 Double Electric Breast Pump
K
22
1708
CIMILRE Free-T2 Plus
K
22
0926
Spectra Wearable
K
22
1598
Wearable breast pump
K
22
1576
Ameda Pearl Electric Breast Pump
K
21
1016
Powered Breast Pump (Models 7V and 7X)
K
22
0309
Wearable Breast Pump (Model S10)
K
22
0596
Wearable Breast Pump (Model S9)
K
21
2564
Electric Breast Pump
K
21
2773
ARDO Alyssa
K
21
2955
Fit Pro Breast Pump
K
21
2180
Wearable Breast Pump (Model S12)
K
21
1024
Electric Breast Pump
K
21
3311
Lucy Breast Pump
K
21
2884
Electric breast pump
K
21
1755
Electric Breast Pump
K
21
0124
Synergy Gold (SG) Portable (Models MM011450 and MM011460)
K
20
2802
TT Electric Breast Pump, TT Double Electric Breast Pump
K
21
0936
Elvie Stride
K
21
0759
Solo, Swing Maxi
K
20
3148
Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
K
20
1152
Electric Breast Pump
K
20
3570
Mya Joy PLUS Breast Pump
K
20
1903
Electric breast pump (Models: RH-228 and RH-338)
K
20
2037
imani i2
K
20
2045
imani i1
K
20
0675
Hi bebe super (Models BT-150S and BT-150L)
K
20
3383
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
K
20
1381
Philips Avent Single/Double electric breast pump Advanced
K
19
3449
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
K
20
0508
Pump In Style
K
20
0712
Rumble Tuff Electric Breast Pump
K
19
2640
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
K
20
0406
Evolve Breast Pump
K
19
1109
Spectra Q
K
19
1802
Electric Breast Pump
K
19
0465
Evolve Breast Pump
K
19
1653
Freestyle Flex
K
19
1208
Spectra Cashmere
K
19
1577
Willow Wearable Breast Pump 2.0
K
19
0810
OPERA, OPERA eco
K
18
2749
Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
K
18
2413
Electric Breast Pump
K
18
1784
Spectra S3 Plus
K
18
1937
Pump In Style Advanced, Advanced Personal Double Breastpump
K
18
1863
Elvie Pump
K
18
0075
MINUET LCD, MINUET LCD eco
K
17
2842
GCE704 Breast Pump
K
17
3699
The Pump by Babyation
K
17
2989
Electric Breast Pump
K
17
2067
One Mum Pumpset
K
17
2772
Freemie Independence, Freemie Liberty
K
16
3183
Yooeehouse Breast Pump
K
17
0722
Moxxly Flow Collection System
K
16
3136
Youha electric breast pump
K
16
2415
Spectra 9Plus
K
16
2870
CIMLRE F1 and CIMILRE S3
K
16
2747
Proture Double Electric Breast Pump
K
16
1725
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
K
16
0274
Hi bebe plus
K
16
1532
Philips Avent Comfort Single/Twin Electric Breast Pump
K
16
1266
Athena Breast Pump
K
16
0511
Naya Breast Pump System
K
15
0476
Spectra S1Plus and Spectra S2 Plus
K
15
1284
Electric Double Breast Pumps
K
15
0923
Breast Pump
K
15
1632
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
K
15
0721
ARDO Calypso Pro Powered Breast Pump
K
14
3585
Electric Breast Pump
K
15
0499
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
K
14
3574
Melodi Prime Breast Pump
K
14
2479
MEGNA BREAST PUMPS
K
13
2220
PJ'S SERENITY
K
14
2168
NATURE'S BOND 600 AND NATURE'S BOND 603
K
14
1742
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
K
13
2882
ELECTRIC BREAST PUMP
K
13
0349
FREEMIE BREAST COLLECTION SYSTEM
K
13
1153
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K
13
1027
MEMORY PUMP MODEL Y4947
K
12
1478
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
K
12
2474
LANSINOH POWERED ELECTRIC BREAST PUMP
K
11
3315
RUMBLE TUFF
K
12
1322
CLOSER TO NATURE
K
11
2856
LUCINA-MELODI
K
11
3664
CLOSER TO NATURE ELECTRIC BREAST PUMP
K
11
1411
FREEMIE (R)
K
10
2516
LUCINA MODEL MELODI
K
11
0343
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
K
10
2600
SIMPLYGO BREAST PUMP
K
10
1157
E-BASIC SINGLE BREAST PUMP
K
09
3145
SPECTRA SERIES BREAST PUMP
K
09
3648
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
K
10
0929
UNIMOM ALLEGRO
K
10
0435
AMEDA PLATINUM BREAST PUMP
K
10
0385
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
K
09
2783
DEBP
K
09
2770
SIMPLYGO HANDS FREE BREAST PUMP
K
08
1463
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
K
08
1932
ENDEARE BREAST PUMP
K
08
2802
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
K
08
2307
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
K
07
0435
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
K
06
1013
PLAYTEX EMBRACE PETITE BREAST PUMP
K
05
3052
MEDELA SWING BREAST PUMP
K
05
1926
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
K
05
2909
EVENFLO ELAN BREAST PUMP
K
05
2047
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
K
05
1112
WHITTLESTONE EXPRESSER
K
05
1413
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
K
04
3098
GERBER DOUBLE ELECTRIC BREAST PUMP
K
03
3131
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
K
03
2566
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
K
03
1614
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
K
02
1739
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
K
02
2933
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
K
02
2594
PLAYTEX BREAST PUMP
K
02
2140
WHISPER WEAR BREAST PUMP
K
02
0375
THE NURTURE III BREAST PUMP
K
02
0518
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K
01
2275
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
K
00
2696
WHITTLESTONE BREASTPUMP
K
98
1549
LACTATION TECHNIQUES MODEL B
K
98
3776
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
K
97
3501
EXPRESSE AND PREMIER POWERED BREAST PUMPS
K
97
0488
HYDROCHECK MICRO FILTER
K
97
1543
LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
K
96
4679
WHITE RIVER AUTOMATIC BREAST PUMP
K
96
4396
DOUBLE UP BREAST PUMP
K
96
0727
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
K
96
4403
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
K
96
0726
EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
K
95
2712
WHITE RIVER BATTERY-POWERED BREAST PUMP
K
95
0750
MEDELAS BREAST PUMP
K
95
0531
EGNELL ELITE
K
94
2534
GERBER NATURAL COMFORT BATTERY BREAST PUMP
K
92
4312
NURTURE III
K
94
1112
SINGLE HANDED BREAST PUMP
K
93
6309
DELUXE MAGMAG BREAST PUMP
K
93
5249
ADVANCED MAGMAG AC/BATTERY BREAST PUMP
K
92
1261
ELECTRIC POWERED BREAST PUMP
K
90
1344
MEDELA BATTERY OPERATED BREAST PUMP
K
89
5114
FRANK MILK PUMP
K
89
3545
IVEX MODEL NO. BP 3000 BREASTPUMP
K
89
1996
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
K
89
0588
GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
K
87
5300
MEDELA BREAST-PUMP LACTINA
K
87
4071
MOTHER'S MILK BAG
K
86
1513
LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP
K
85
3326
WATER DRIVEN BREAST PUMP BY BABY NURSE
K
85
3107
AXICARE CM-14 AUTOMATIC BREAST PUMP
K
85
2460
GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
K
85
0705
THE WHITE RIVER PORTA-ELEC-BREAST PUMP
K
85
0753
NATURAL MOTHER BREAST PUMP
K
84
4013
CARE ELECTRIC BREAST PUMP
K
84
4307
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
K
84
2766
CRYSTAL MEDICAL MILK COLLECTION KIT
K
81
1403
AXICARE BREAST PUMP MODEL
K
81
0065
SCOTT CM42 PASTEURIZER
K
80
1862
MEDELA ELECTRIC BREAST PUMP
K
80
1246
OXFORD HUMAN MILK PASTEURISER
HGY
Pump, Breast, Non-Powered
HGZ
Heater, Perineal, Direct Contact
HHA
Heater, Perineal, Radiant, Non-Contact
HHD
Pad, Menstrual, Unscented
HHE
Cup, Menstrual
HHI
System, Abortion, Vacuum
HHL
Pad, Menstrual, Scented
HHQ
System, Abortion, Metreurynter-Balloon
HHS
Transcervical Contraceptive Tubal Occlusion Device
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
HIL
Tampon, Menstrual, Scented, Deodorized
HIS
Condom
KND
Heater, Perineal
KNE
Set, Anesthesia, Obstetric
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
KXQ
Vibrator For Therapeutic Use, Genital
LTZ
Condom With Nonoxynol-9
LZL
Micro-Condom
MBU
Single-Use Internal Condom
MFD
Cannula, Intrauterine Insemination
NUR
Pad, Interlabial
MOL
Condom, Synthetic
MSC
Barrier, Std, Oral Sex
NBV
Device, Engorgement, Clitoral
NRC
Pads, Menstrual, Scented-Deodorized
NUC
Lubricant, Personal
NUQ
Pad, Menstrual, Reusable
OBB
Kit, Conception-Assist, Home Use
OBY
Condom, Female, Animal Tissue
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
OHH
Breast Pump Kit
OKW
Seminal Fluid Collection Kit
OOA
Hemorrhoid Prevention Pressure Wedge
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
PVT
Maternity Kit
PVU
Obstetrical Anesthesia Kit
PVV
Paracervical Anesthesia Kit
PVW
Pudendal Anesthesia Kit
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
QPD
Personal Lubricant Ring
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-f—obstetrical-and-gynecological-therapeutic-devices
/
HGX
/
K053052
View Source
MEDELA SWING BREAST PUMP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053052
510(k) Type
Traditional
Applicant
MEDELA AG
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
5/2/2006
Days to Decision
183 days
Submission Type
Summary