Cleared Traditional

K203768 - Omnipod 5 ACE Pump (Pod) (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203768 · Insulet Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
400d
Days
Class 2
Risk

K203768 is an FDA 510(k) clearance for the Omnipod 5 ACE Pump (Pod). Classified as Alternate Controller Enabled Insulin Infusion Pump (product code QFG), Class II - Special Controls.

Submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on January 27, 2022 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5730 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Insulet Corporation devices

Submission Details

510(k) Number K203768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2020
Decision Date January 27, 2022
Days to Decision 400 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
312d slower than avg
Panel avg: 88d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFG Alternate Controller Enabled Insulin Infusion Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5730
Definition An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QFG Alternate Controller Enabled Insulin Infusion Pump

All 26
Devices cleared under the same product code (QFG) and FDA review panel - the closest regulatory comparables to K203768.
iLet ACE Pump
K253976 · Beta Bionics, Inc. · Apr 2026
MiniMed Flex pump
K253743 · Medtronic Minimed, Inc. · Mar 2026
MiniMed 780G Insulin Pump (MMT-1884)
K253470 · Medtronic Minimed, Inc. · Jan 2026
Tandem Mobi insulin pump with interoperable technology
K253074 · Tandem Diabetes Care, Inc. · Nov 2025
iLet ACE Pump
K252770 · Beta Bionics, Inc. · Sep 2025
t:slim X2 insulin pump with interoperable technology
K250792 · Tandem Diabetes Care, Inc. · Sep 2025