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)
Show All 83 Submissions
- 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
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192659
- 510(k) Type
- Traditional
- Applicant
- Insulet Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/21/2019
- Days to Decision
- 26 days
- Submission Type
- Summary