Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Insulet Corporation — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
400 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261461 | Omnipod 6 algorithm | Insulet Corporation | 2026-06-29 | 56 | 0 |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | 2025-12-03 | 176 | 0 |
| K241777 | SmartAdjust™ Technology | Insulet Corporation | 2024-08-26 | 67 | 0 |
| K232741 | SmartAdjust(TM) technology | Insulet Corporation | 2024-05-29 | 265 | 0 |
| K231824 | SmartBolus Calculator | Insulet Corporation | 2023-10-18 | 119 | 0 |
| K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023-10-18 | 119 | 5 |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023-04-24 | 171 | 0 |
| K220394 | SmartAdjust(TM) technology | Insulet Corporation | 2022-08-19 | 189 | 0 |
| K222239 | SmartBolus Calculator | Insulet Corporation | 2022-08-19 | 24 | 0 |
| K203774 | SmartAdjust technology | Insulet Corporation | 2022-01-27 | 400 | 0 |
| K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | 2022-01-27 | 400 | 2 |
| K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022-01-27 | 400 | 0 |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Ma | Insulet Corporation | 2021-08-13 | 84 | 3 |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Mana | Insulet Corporation | 2019-10-21 | 26 | 0 |
| K191679 | Omnipod DASH Insulin Management System with interoperable te | Insulet Corporation | 2019-09-20 | 88 | 0 |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Mana | Insulet Corporation | 2019-01-08 | 106 | 0 |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018-06-01 | 144 | 0 |
| K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017-04-18 | 245 | 0 |
| K160252 | OmniPod Insulin Management System | Insulet Corporation | 2016-04-27 | 86 | 0 |
| K140439 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2014-11-13 | 265 | 0 |
| K131294 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2013-08-29 | 115 | 0 |
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM | Insulet Corporation | 2012-12-07 | 73 | 8 |
| K111669 | FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULI | Insulet Corporation | 2011-12-15 | 183 | 0 |
| K042792 | IXL-II DIABETES MANAGEMENT SYSTEM | Insulet Corporation | 2005-01-03 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda