FDA applicant

Insulet Corporation

Acton, MA25 decisions2003–202623 recalls

FDA records 25 decisions for Insulet Corporation (Acton, MA) from 2003 to 2026: 25 510(k) clearances. Most are in product codes LZG (Pump, Infusion, Insulin) and QJI (Interoperable Automated Glycemic Controller). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 20 of them its own earlier devices. 23 recalls are linked to its devices, 10 Class I.

FDA’s records also spell it “Insulet Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Insulet Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 5 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2026

2007high 6 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Insulet Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Insulet Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

LZGPump, Infusion, Insulin13decisions
QJIInteroperable Automated Glycemic Controller6decisions
QFGAlternate Controller Enabled Insulin Infusion Pump3decisions
QRXContinuous Glucose Monitor Informed Insulin Dose Calculator3decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 20 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K042792Ixl-II Diabetes Management SystemInsulet Corporation · 20056cite it
K191679Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation · 20194cite it
K122953Omnipod Insulin Managment SystemInsulet Corporation · 20124cite it
K031373Ixl Diabetes Management SystemInsulet Corp. · 20033cite it
K162296OmniPod Insulin Management SystemInsulet Corporation · 20172cite it
K203772Omnipod 5 SmartBolus CalculatorInsulet Corporation · 20222cite it

What has FDA decided for it lately?

K261461Omnipod 6 algorithmInsulet Corporation · 2026
K251779Omnipod 5 algorithmInsulet Corporation · 2025
K241777SmartAdjust™ TechnologyInsulet Corporation · 2024
K232741SmartAdjust (TM) technologyInsulet Corporation · 2024
K231826Omnipod 5 ACE PumpInsulet Corporation · 20233 Class I recalls
K231824SmartBolus CalculatorInsulet Corporation · 2023
K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023
K222239SmartBolus CalculatorInsulet Corporation · 2022

All 24 as Insulet Corporation →The one decision as Insulet Corp. →

What has been recalled?

23 recalls linked to its devices; the latest:

K231826Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2.…May 20, 2026Class I
K211575Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)…May 20, 2026Class I
K211575Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD-…May 20, 2026Class I
K231826Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Mar 12, 2026Class I
K231826The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on…Sep 11, 2025Class II
K231826Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number…May 23, 2025Class II