Insulet Corporation: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Insulet Corporation” (first 2003, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 119 days. Since 2017 the median was 132 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 73 |
| 2013 | 1 | 115 |
| 2014 | 1 | 265 |
| 2015 | 0 | — |
| 2016 | 1 | 86 |
| 2017 | 1 | 245 |
| 2018 | 1 | 144 |
| 2019 | 3 | 88 |
| 2020 | 0 | — |
| 2021 | 1 | 84 |
| 2022 | 5 | 400 |
| 2023 | 3 | 119 |
| 2024 | 2 | 166 |
| 2025 | 1 | 176 |
| 2026 | 1 | 56 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Insulet Corporation took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | 13 | 13 |
| QJI | Interoperable Automated Glycemic Controller | 6 | 6 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 3 | 3 |
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | 3 | 3 |
Review panels
- Clinical Chemistry (25)
Most recent Insulet Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261461 | Omnipod 6 algorithm | QJI | 2026-06-29 | 56 |
| K251779 | Omnipod 5 algorithm | QJI | 2025-12-03 | 176 |
| K241777 | SmartAdjust Technology | QJI | 2024-08-26 | 67 |
| K232741 | SmartAdjust(TM) technology | QJI | 2024-05-29 | 265 |
| K231826 | Omnipod 5 ACE Pump | QFG | 2023-10-18 | 119 |
| K231824 | SmartBolus Calculator | QRX | 2023-10-18 | 119 |
| K223372 | Omnipod GO Insulin Delivery Device | LZG | 2023-04-24 | 171 |
| K222239 | SmartBolus Calculator | QRX | 2022-08-19 | 24 |
| K220394 | SmartAdjust(TM) technology | QJI | 2022-08-19 | 189 |
| K203774 | SmartAdjust technology | QJI | 2022-01-27 | 400 |
15 earlier clearances. See the full list in Caduvo.
Recalls
21 product recalls in 15 recall events; 10 initiated in the last five years. Most recent: 2026-05-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Insulet Corporation is the lead sponsor of 20 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07317102: Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B) (Recruiting, started 2026-03-16)
- NCT07276776: An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes (Completed, started 2025-12-12)
- NCT07039942: French Prospective Multicentric Study in Real World (Recruiting, started 2025-07-23)
- NCT07070830: Simplified Onboarding in Adults With Type 2 Diabetes (Completed, started 2025-07-18)
- NCT07039981: Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes (Active not recruiting, started 2025-07-01)
SEC filings
INSULET CORP (PODD): EDGAR filings, CIK 1145197. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Insulet Corporation (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZG)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZG)
Frequently asked questions
How many FDA 510(k) clearances are listed under Insulet Corporation?
FDA lists 25 510(k) clearances under the applicant name “Insulet Corporation” (first 2003, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Insulet Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Insulet Corporation is 119 days. Since 2017: 132 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Insulet Corporation?
The most frequent FDA product codes under this applicant name are LZG (Pump, Infusion, Insulin, 13); QJI (Interoperable Automated Glycemic Controller, 6); QFG (Alternate Controller Enabled Insulin Infusion Pump, 3).
Next steps
- See all 25 Insulet Corporation clearances with predicates and recalls
- Run predicate analysis for product code LZG, Insulet Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.