Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- HDOValve, Tubal Occlusion3Product Code
- HDRCap, Cervical2Product Code
- HDTDevice, Intrauterine, Contraceptive And Introducer3Product Code
- HDWDiaphragm, Contraceptive (And Accessories)2Product Code
- HEBTampon, Menstrual, Unscented2Product Code
- HECInsufflator, Vaginal1Product Code
- HEDDouche Apparatus, Vaginal, Therapeutic1Product Code
- HEESet, Anesthesia, Paracervical2Product Code
- HEGSet, Anesthesia, Pudendal2Product Code
- HEHChamber, Decompression, Abdominal3Product Code
- HFYBand, Tubal Occlusion3Product Code
- HGBClip, Tubal Occlusion3Product Code
- HGFSource, Abortion Unit, Vacuum2Product Code
- HGGController, Abortion Unit, Vacuum2Product Code
- HGHCannula, Suction, Uterine2Product Code
- HGXPump, Breast, Powered2Product Code
- K240218Electric Breast Pump (F5055)2Cleared 510(K)
- K242125Elvie Stride 22Cleared 510(K)
- K241004Wearable 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)2Cleared 510(K)
- K231969BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)2Cleared 510(K)
- K241705MilkMate 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)2Cleared 510(K)
- K240536Wearable Breast Pump (Model S32)2Cleared 510(K)
- K241506Annabella Double Breast Pump (ADO-US23-1000)2Cleared 510(K)
- K232774Wearable Breast Pump,Model S182Cleared 510(K)
- K233913Electric 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)2Cleared 510(K)
- K232477Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)2Cleared 510(K)
- K232608Duo Hands-free Breast Pump2Cleared 510(K)
- K232047VIVACE2Cleared 510(K)
- K233136Hygeia Express Powered Breast Pump2Cleared 510(K)
- K233880Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)2Cleared 510(K)
- K231785Perifit Pump2Cleared 510(K)
- K232466Electric Breast Pump, model: YM-81662Cleared 510(K)
- K230481Evenflo Premium Double Electric Breast Pump (Model 4018)2Cleared 510(K)
- K231595Electric Breast Pump2Cleared 510(K)
- K230570Willow Generation 3 Breast Pump2Cleared 510(K)
- K230102Smart double sides wearable breast pump, Electric bilateral breast pump2Cleared 510(K)
- K230672Annabella Breast Pump2Cleared 510(K)
- K223886Wearable Breast Pump (Model S18)2Cleared 510(K)
- K230469Compact Wearable Pump2Cleared 510(K)
- K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)2Cleared 510(K)
- K223329Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)2Cleared 510(K)
- K230590ARDO Bellis2Cleared 510(K)
- K223084MilkMate Breast Pump2Cleared 510(K)
- K223693Electric breast pump (model: M5)2Cleared 510(K)
- K222573imani i2Plus Breast Pump2Cleared 510(K)
- K222782Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)2Cleared 510(K)
- K222045Wearable Breast Pump (Model S1DW)2Cleared 510(K)
- K222726Smartpump 3.0 Double Electric Breast Pump2Cleared 510(K)
- K221708CIMILRE Free-T2 Plus2Cleared 510(K)
- K220926Spectra Wearable2Cleared 510(K)
- K221598Wearable breast pump2Cleared 510(K)
- K221576Ameda Pearl Electric Breast Pump2Cleared 510(K)
- K211016Powered Breast Pump (Models 7V and 7X)2Cleared 510(K)
- K220309Wearable Breast Pump (Model S10)2Cleared 510(K)
- K220596Wearable Breast Pump (Model S9)2Cleared 510(K)
- K212564Electric Breast Pump2Cleared 510(K)
- K212773ARDO Alyssa2Cleared 510(K)
- K212955Fit Pro Breast Pump2Cleared 510(K)
- K212180Wearable Breast Pump (Model S12)2Cleared 510(K)
- K211024Electric Breast Pump2Cleared 510(K)
- K213311Lucy Breast Pump2Cleared 510(K)
- K212884Electric breast pump2Cleared 510(K)
- K211755Electric Breast Pump2Cleared 510(K)
- K210124Synergy Gold (SG) Portable (Models MM011450 and MM011460)2Cleared 510(K)
- K202802TT Electric Breast Pump, TT Double Electric Breast Pump2Cleared 510(K)
- K210936Elvie Stride2Cleared 510(K)
- K210759Solo, Swing Maxi2Cleared 510(K)
- K203148Youha 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)2Cleared 510(K)
- K201152Electric Breast Pump2Cleared 510(K)
- K203570Mya Joy PLUS Breast Pump2Cleared 510(K)
- K201903Electric breast pump (Models: RH-228 and RH-338)2Cleared 510(K)
- K202037imani i22Cleared 510(K)
- K202045imani i12Cleared 510(K)
- K200675Hi bebe super (Models BT-150S and BT-150L)2Cleared 510(K)
- K203383Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/622Cleared 510(K)
- K201381Philips Avent Single/Double electric breast pump Advanced2Cleared 510(K)
- K193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)2Cleared 510(K)
- K200508Pump In Style2Cleared 510(K)
- K200712Rumble Tuff Electric Breast Pump2Cleared 510(K)
- K192640Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump2Cleared 510(K)
- K200406Evolve Breast Pump2Cleared 510(K)
- K191109Spectra Q2Cleared 510(K)
- K191802Electric Breast Pump2Cleared 510(K)
- K190465Evolve Breast Pump2Cleared 510(K)
- K191653Freestyle Flex2Cleared 510(K)
- K191208Spectra Cashmere2Cleared 510(K)
- K191577Willow Wearable Breast Pump 2.02Cleared 510(K)
- K190810OPERA, OPERA eco2Cleared 510(K)
- K182749Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump2Cleared 510(K)
- K182413Electric Breast Pump2Cleared 510(K)
- K181784Spectra S3 Plus2Cleared 510(K)
- K181937Pump In Style Advanced, Advanced Personal Double Breastpump2Cleared 510(K)
- K181863Elvie Pump2Cleared 510(K)
- K180075MINUET LCD, MINUET LCD eco2Cleared 510(K)
- K172842GCE704 Breast Pump2Cleared 510(K)
- K173699The Pump by Babyation2Cleared 510(K)
- K172989Electric Breast Pump2Cleared 510(K)
- K172067One Mum Pumpset2Cleared 510(K)
- K172772Freemie Independence, Freemie Liberty2Cleared 510(K)
- K163183Yooeehouse Breast Pump2Cleared 510(K)
- K170722Moxxly Flow Collection System2Cleared 510(K)
- K163136Youha electric breast pump2Cleared 510(K)
- K162415Spectra 9Plus2Cleared 510(K)
- K162870CIMLRE F1 and CIMILRE S32Cleared 510(K)
- K162747Proture Double Electric Breast Pump2Cleared 510(K)
- K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail2Cleared 510(K)
- K160274Hi bebe plus2Cleared 510(K)
- K161532Philips Avent Comfort Single/Twin Electric Breast Pump2Cleared 510(K)
- K161266Athena Breast Pump2Cleared 510(K)
- K160511Naya Breast Pump System2Cleared 510(K)
- K150476Spectra S1Plus and Spectra S2 Plus2Cleared 510(K)
- K151284Electric Double Breast Pumps2Cleared 510(K)
- K150923Breast Pump2Cleared 510(K)
- K151632Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental2Cleared 510(K)
- K150721ARDO Calypso Pro Powered Breast Pump2Cleared 510(K)
- K143585Electric Breast Pump2Cleared 510(K)
- K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty2Cleared 510(K)
- K143574Melodi Prime Breast Pump2Cleared 510(K)
- K142479MEGNA BREAST PUMPS2Cleared 510(K)
- K132220PJ'S SERENITY2Cleared 510(K)
- K142168NATURE'S BOND 600 AND NATURE'S BOND 6032Cleared 510(K)
- K141742ARDO CARUM AND CALYPSO POWERED BREAST PUMPS2Cleared 510(K)
- K132882ELECTRIC BREAST PUMP2Cleared 510(K)
- K130349FREEMIE BREAST COLLECTION SYSTEM2Cleared 510(K)
- K131153EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP2Cleared 510(K)
- K131027MEMORY PUMP MODEL Y49472Cleared 510(K)
- K121478NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP2Cleared 510(K)
- K122474LANSINOH POWERED ELECTRIC BREAST PUMP2Cleared 510(K)
- K113315RUMBLE TUFF2Cleared 510(K)
- K121322CLOSER TO NATURE2Cleared 510(K)
- K112856LUCINA-MELODI2Cleared 510(K)
- K113664CLOSER TO NATURE ELECTRIC BREAST PUMP2Cleared 510(K)
- K111411FREEMIE (R)2Cleared 510(K)
- K102516LUCINA MODEL MELODI2Cleared 510(K)
- K110343TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP2Cleared 510(K)
- K102600SIMPLYGO BREAST PUMP2Cleared 510(K)
- K101157E-BASIC SINGLE BREAST PUMP2Cleared 510(K)
- K093145SPECTRA SERIES BREAST PUMP2Cleared 510(K)
- K093648SIMPLISSE ELECTRIC BREASTFEEDING COMPANION2Cleared 510(K)
- K100929UNIMOM ALLEGRO2Cleared 510(K)
- K100435AMEDA PLATINUM BREAST PUMP2Cleared 510(K)
- K100385NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP2Cleared 510(K)
- K092783DEBP2Cleared 510(K)
- K092770SIMPLYGO HANDS FREE BREAST PUMP2Cleared 510(K)
- K081463MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP2Cleared 510(K)
- K081932ENDEARE BREAST PUMP2Cleared 510(K)
- K082802MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B2Cleared 510(K)
- K082307EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT2Cleared 510(K)
- K070435DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 14002Cleared 510(K)
- K061013PLAYTEX EMBRACE PETITE BREAST PUMP2Cleared 510(K)
- K053052MEDELA SWING BREAST PUMP2Cleared 510(K)
- K051926LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP2Cleared 510(K)
- K052909EVENFLO ELAN BREAST PUMP2Cleared 510(K)
- K052047ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 1012Cleared 510(K)
- K051112WHITTLESTONE EXPRESSER2Cleared 510(K)
- K051413ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 1002Cleared 510(K)
- K043098GERBER DOUBLE ELECTRIC BREAST PUMP2Cleared 510(K)
- K033131NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/10682Cleared 510(K)
- K032566NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP2Cleared 510(K)
- K031614MEDELA PUMP IN STYLE ADVANCED BREAST PUMP2Cleared 510(K)
- K021739LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 10022Cleared 510(K)
- K022933EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT2Cleared 510(K)
- K022594PLAYTEX BREAST PUMP2Cleared 510(K)
- K022140WHISPER WEAR BREAST PUMP2Cleared 510(K)
- K020375THE NURTURE III BREAST PUMP2Cleared 510(K)
- K020518MEDELA SYMPHONY BREAST PUMP, MODEL 0242Cleared 510(K)
- K012275PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP2Cleared 510(K)
- K002696WHITTLESTONE BREASTPUMP2Cleared 510(K)
- K981549LACTATION TECHNIQUES MODEL B2Cleared 510(K)
- K983776EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP2Cleared 510(K)
- K973501EXPRESSE AND PREMIER POWERED BREAST PUMPS2Cleared 510(K)
- K970488HYDROCHECK MICRO FILTER2Cleared 510(K)
- K971543LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP2Cleared 510(K)
- K964679WHITE RIVER AUTOMATIC BREAST PUMP2Cleared 510(K)
- K964396DOUBLE UP BREAST PUMP2Cleared 510(K)
- K960727EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT2Cleared 510(K)
- K964403SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)2Cleared 510(K)
- K960726EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP2Cleared 510(K)
- K952712WHITE RIVER BATTERY-POWERED BREAST PUMP2Cleared 510(K)
- K950750MEDELAS BREAST PUMP2Cleared 510(K)
- K950531EGNELL ELITE2Cleared 510(K)
- K942534GERBER NATURAL COMFORT BATTERY BREAST PUMP2Cleared 510(K)
- K924312NURTURE III2Cleared 510(K)
- K941112SINGLE HANDED BREAST PUMP2Cleared 510(K)
- K936309DELUXE MAGMAG BREAST PUMP2Cleared 510(K)
- K935249ADVANCED MAGMAG AC/BATTERY BREAST PUMP2Cleared 510(K)
- K921261ELECTRIC POWERED BREAST PUMP2Cleared 510(K)
- K901344MEDELA BATTERY OPERATED BREAST PUMP2Cleared 510(K)
- K895114FRANK MILK PUMP2Cleared 510(K)
- K893545IVEX MODEL NO. BP 3000 BREASTPUMP2Cleared 510(K)
- K891996GERBER PRECIOUS CARE ELECTRIC BREAST PUMP2Cleared 510(K)
- K890588GENTLE EXPRESSIONS ELECTRIC BREAST PUMP2Cleared 510(K)
- K875300MEDELA BREAST-PUMP LACTINA2Cleared 510(K)
- K874071MOTHER'S MILK BAG2Cleared 510(K)
- K861513LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP2Cleared 510(K)
- K853326WATER DRIVEN BREAST PUMP BY BABY NURSE2Cleared 510(K)
- K853107AXICARE CM-14 AUTOMATIC BREAST PUMP2Cleared 510(K)
- K852460GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY2Cleared 510(K)
- K850705THE WHITE RIVER PORTA-ELEC-BREAST PUMP2Cleared 510(K)
- K850753NATURAL MOTHER BREAST PUMP2Cleared 510(K)
- K844013CARE ELECTRIC BREAST PUMP2Cleared 510(K)
- K844307EGNELL-LACT B BATTERY-OPERATED BREAST PUMP2Cleared 510(K)
- K842766CRYSTAL MEDICAL MILK COLLECTION KIT2Cleared 510(K)
- K811403AXICARE BREAST PUMP MODEL2Cleared 510(K)
- K810065SCOTT CM42 PASTEURIZER2Cleared 510(K)
- K801862MEDELA ELECTRIC BREAST PUMP2Cleared 510(K)
- K801246OXFORD HUMAN MILK PASTEURISER2Cleared 510(K)
- HGYPump, Breast, Non-Powered1Product Code
- HGZHeater, Perineal, Direct Contact2Product Code
- HHAHeater, Perineal, Radiant, Non-Contact2Product Code
- HHDPad, Menstrual, Unscented1Product Code
- HHECup, Menstrual2Product Code
- HHISystem, Abortion, Vacuum2Product Code
- HHLPad, Menstrual, Scented2Product Code
- HHQSystem, Abortion, Metreurynter-Balloon3Product Code
- HHSTranscervical Contraceptive Tubal Occlusion Device3Product Code
- HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic Use3Product Code
- HILTampon, Menstrual, Scented, Deodorized2Product Code
- HISCondom2Product Code
- KNDHeater, Perineal2Product Code
- KNESet, Anesthesia, Obstetric2Product Code
- KNHLaparoscopic Contraceptive Tubal Occlusion Device3Product Code
- KXQVibrator For Therapeutic Use, Genital2Product Code
- LTZCondom With Nonoxynol-92Product Code
- LZLMicro-Condom3Product Code
- MBUSingle-Use Internal Condom2Product Code
- MFDCannula, Intrauterine Insemination2Product Code
- NURPad, Interlabial1Product Code
- MOLCondom, Synthetic2Product Code
- MSCBarrier, Std, Oral Sex2Product Code
- NBVDevice, Engorgement, Clitoral2Product Code
- NRCPads, Menstrual, Scented-Deodorized1Product Code
- NUCLubricant, Personal2Product Code
- NUQPad, Menstrual, Reusable1Product Code
- OBBKit, Conception-Assist, Home Use2Product Code
- OBYCondom, Female, Animal Tissue3Product Code
- PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible2Product Code
- OHHBreast Pump Kit2Product Code
- OKWSeminal Fluid Collection Kit2Product Code
- OOAHemorrhoid Prevention Pressure Wedge2Product Code
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PAIMesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery2Product Code
- PVTMaternity Kit1Product Code
- PVUObstetrical Anesthesia Kit2Product Code
- PVVParacervical Anesthesia Kit2Product Code
- PVWPudendal Anesthesia Kit2Product Code
- PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure1Product Code
- PYTDevice, Fertility Diagnostic, Contraceptive, Software Application2Product Code
- QPDPersonal Lubricant Ring2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K161725
- 510(k) Type
- Traditional
- Applicant
- MEDELA, INC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/28/2016
- Days to Decision
- 128 days
- Submission Type
- Summary