Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Insulet and its 1 subsidiaries with 29 device recalls and 27 510(k) clearances. The most recent is a 510(k) clearance dated Jun 29, 2026: Omnipod 6 algorithm.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Insulet and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 29, 2026 | Omnipod 6 algorithmK261461 · QJI | 510(k) clearances |
| Dec 3, 2025 | Omnipod 5 algorithmK251779 · QJI | 510(k) clearances |
| Aug 26, 2024 | SmartAdjust™ TechnologyK241777 · QJI | 510(k) clearances |
| May 29, 2024 | SmartAdjust(TM) technologyK232741 · QJI | 510(k) clearances |
| Oct 18, 2023 | Omnipod 5 ACE PumpK231826 · QFG | 510(k) clearances |
| Oct 18, 2023 | SmartBolus CalculatorK231824 · QRX | 510(k) clearances |
| Apr 24, 2023 | Omnipod GO Insulin Delivery DeviceK223372 · LZG | 510(k) clearances |
| Aug 19, 2022 | SmartBolus CalculatorK222239 · QRX | 510(k) clearances |
| Nov 19, 2013 | Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); DistributedClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
| Nov 19, 2013 | Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). ManClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
| Nov 19, 2013 | Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). ManufacClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
| Nov 19, 2013 | Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) ManufactClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
| Nov 19, 2013 | Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) DistributClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
| Nov 19, 2013 | Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) DistributedClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
| Nov 19, 2013 | Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by AsaClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
| Nov 19, 2013 | Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). ManufaClass II · Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set a | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
