# Insulet Corporation

- Location (FDA's records): Acton, MA
- FDA decisions: 25 (2003–2026): 25 510(k) clearances
- Names in FDA's records: Insulet Corporation (24); Insulet Corp. (1)
- Product codes: LZG (13), QJI (6), QFG (3), QRX (3)
- 510(k) review time since 2016: median 103 days, against 140 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 24 (20 its own); citations of its devices by later devices: 32 (20 its own)
- Recalls linked to its devices: 23 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tandem Diabetes Care, Inc.: 2 (https://510kreport.com/company/tandem-diabetes-care)
- Valeritas, LLC: 1 (https://510kreport.com/company/valeritas)
- DreaMed Diabetes, Ltd.: 1 (https://510kreport.com/company/dreamed-diabetes)

## Firms that cite its devices most
- Medingo, Ltd.: 4 (https://510kreport.com/company/medingo)
- Animas Corp.: 1 (https://510kreport.com/company/animas)
- Welldoc, Inc.: 1 (https://510kreport.com/company/welldoc)
- Biovalve Technologies, Inc.: 1 (https://510kreport.com/company/biovalve-technologies)
- Embecta Medical I, LLC: 1 (https://510kreport.com/company/embecta-medical-i)
- Roche Diabetes Care, Inc.: 1 (https://510kreport.com/company/roche-diabetes-care)
- Triple Jump Israel, Ltd.: 1 (https://510kreport.com/company/triple-jump-israel)
- Abbott Diabetes Care, Inc.: 1 (https://510kreport.com/company/abbott-diabetes-care)

## Its most-cited devices
- K042792: Ixl-II Diabetes Management System (2005), cited by 6
- K191679: Omnipod DASH Insulin Management System with interoperable technology (2019), cited by 4
- K122953: Omnipod Insulin Managment System (2012), cited by 4
- K031373: Ixl Diabetes Management System (2003), cited by 3
- K162296: OmniPod Insulin Management System (2017), cited by 2
- K203772: Omnipod 5 SmartBolus Calculator (2022), cited by 2

## Recent decisions
- K261461: Omnipod 6 algorithm (Jun 29, 2026)
- K251779: Omnipod 5 algorithm (Dec 3, 2025)
- K241777: SmartAdjust™ Technology (Aug 26, 2024)
- K232741: SmartAdjust (TM) technology (May 29, 2024)
- K231826: Omnipod 5 ACE Pump (Oct 18, 2023)
- K231824: SmartBolus Calculator (Oct 18, 2023)
- K223372: Omnipod GO Insulin Delivery Device (Apr 24, 2023)
- K222239: SmartBolus Calculator (Aug 19, 2022)

Source page: https://510kreport.com/company/insulet