Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- QFGAlternate Controller Enabled Insulin Infusion Pump2Product Code
- LZFPump, Infusion, Analytical Sampling2Product Code
- LZGPump, Infusion, Insulin2Product Code
- K240158Modular Medical MODD1 Insulin Delivery System2Cleared 510(K)
- K241622Extended Reservoir; MiniMed Reservoir2Cleared 510(K)
- K223372Omnipod GO Insulin Delivery Device2Cleared 510(K)
- K210714Extended Reservoir2Cleared 510(K)
- K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System2Cleared 510(K)
- K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management System2Cleared 510(K)
- K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management System2Cleared 510(K)
- K180045Omnipod DASH Insulin Management System2Cleared 510(K)
- K162296OmniPod Insulin Management System2Cleared 510(K)
- K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater2Cleared 510(K)
- K160056t:slim Insulin Delivery System2Cleared 510(K)
- K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater2Cleared 510(K)
- K160252OmniPod Insulin Management System2Cleared 510(K)
- K143189t:flex Insulin Delivery System2Cleared 510(K)
- K142619Snap Insulin Pump System2Cleared 510(K)
- K140439OMNIPOD INSULIN MANAGEMENT SYSTEM2Cleared 510(K)
- K141758T:SLIM INSULIN DELIVERY SYSTEM2Cleared 510(K)
- K133593T:SLIM INSULIN DELIVERY SYSTEM2Cleared 510(K)
- K131294OMNIPOD INSULIN MANAGEMENT SYSTEM2Cleared 510(K)
- K122483PEARL DIABETES MANAGEMENT SYSTEM2Cleared 510(K)
- K122953OMNIPOD INSULIN MANAGMENT SYSTEM2Cleared 510(K)
- K111353ACCU-CHECK COMBO SYSTEM2Cleared 510(K)
- K120206MEDTRONIC MINIMED PARADIGM INSULIN PUMPS2Cleared 510(K)
- K111669FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS2Cleared 510(K)
- K111210T:SLIM (TM) INSULIN DELIVERY SYSTEM2Cleared 510(K)
- K100567PEARL DIABETES MANAGEMENT SYSTEM2Cleared 510(K)
- K103825V-GO INSULIN DELIVERY SYSTEM2Cleared 510(K)
- K100504V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO402Cleared 510(K)
- K093364SOLO MICROPUMP INSULIN DELIVERY SYSTEM2Cleared 510(K)
- K090245SOLO INSULIN PATCH PUMP2Cleared 510(K)
- K083225FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K082590SYMPHONY METER REMOTE2Cleared 510(K)
- K082595MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K080639SYMPHONY GLUCOSE MANAGEMENT SYSTEM2Cleared 510(K)
- K070844NILIMEDIX ADI2Cleared 510(K)
- K073356PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-7152Cleared 510(K)
- K071788AVIATOR INSULIN PUMP2Cleared 510(K)
- K071613AMIGO INSULIN PUMP2Cleared 510(K)
- K063674EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K063126DANA DIABECARE IIS2Cleared 510(K)
- K062323DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-18172Cleared 510(K)
- K060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA2Cleared 510(K)
- K053177MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E2Cleared 510(K)
- K051041INSULIN PUMP2Cleared 510(K)
- K050760ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K050971BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)2Cleared 510(K)
- K050312AMIGO INSULIN PUMP2Cleared 510(K)
- K042887ACCU-CHEK SPIRIT2Cleared 510(K)
- K042792IXL-II DIABETES MANAGEMENT SYSTEM2Cleared 510(K)
- K042873ANIMAS MODEL IR1250 INSULIN INFUSION PUMP2Cleared 510(K)
- K043000MODIFICATION TO D-TRONPLUS2Cleared 510(K)
- K041318MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP2Cleared 510(K)
- K041317MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP2Cleared 510(K)
- K031738SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER2Cleared 510(K)
- K040676MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-7152Cleared 510(K)
- K031373IXL DIABETES MANAGEMENT SYSTEM2Cleared 510(K)
- K031541PARADIGMPAL, MODEL MMT-73302Cleared 510(K)
- K032164DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 73332Cleared 510(K)
- K032257MODEL IR 1200 INSULIN PUMP2Cleared 510(K)
- K030531MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER2Cleared 510(K)
- K022394EZMANAGER PLUS2Cleared 510(K)
- K023471DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP2Cleared 510(K)
- K022831MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP2Cleared 510(K)
- K020655DELTEC INSULIN INFUSION PUMP AND ACCESSORIES2Cleared 510(K)
- K022317DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS2Cleared 510(K)
- K021725DISETRONIC D-TRON INSULIN INFUSION PUMP2Cleared 510(K)
- K013309GLUCOPRO EVO INFUSION PUMP2Cleared 510(K)
- K021439MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO2Cleared 510(K)
- K013807MICROJET QUARK, MODEL U100 OR U402Cleared 510(K)
- K001604DANA DIABECARE2Cleared 510(K)
- K993184R1000 SERIES INSULIN PUMP2Cleared 510(K)
- K994186DISETRONIC D-TRON INSULIN INFUSION PUMP2Cleared 510(K)
- K993012MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-73112Cleared 510(K)
- K991376DAHEDI INSULIN INFUSION PUMP2Cleared 510(K)
- K990801MINIMED 508 INSULIN PUMP2Cleared 510(K)
- K973044DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP2Cleared 510(K)
- K972107MINIMED INFUSION PUMP, MODEL 507C2Cleared 510(K)
- K963948MINIMED INSULIN PUMP, MODEL 5052Cleared 510(K)
- K960001MINIMED INFUSION PUMP, MODEL MMT-5072Cleared 510(K)
- K905693H-TRON V 100 INSULIN INFUSION PUMP2Cleared 510(K)
- K901588MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP2Cleared 510(K)
- K900498MODIFIED BETATRON IV INSULIN INFUSION SYSTEM2Cleared 510(K)
- K884978PHARMA-PLAST INSULIN INFUSION SET2Cleared 510(K)
- Subpart F—Immunological Test SystemsCFR Sub-Part
- 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
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
t:flex Insulin Delivery System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K143189
- 510(k) Type
- Traditional
- Applicant
- Tandem Diabetes Care, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/9/2015
- Days to Decision
- 65 days
- Submission Type
- Summary