Cleared Traditional

DEKA ACE Pump System (K233952) - FDA 510(k) Clearance

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

K233952 · Deka Research and Development · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
89d
Days
Class 2
Risk

K233952 is an FDA 510(k) clearance for the DEKA ACE Pump System. Classified as Alternate Controller Enabled Insulin Infusion Pump (product code QFG), Class II - Special Controls.

Submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on March 13, 2024 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deka Research and Development devices

Submission Details

510(k) Number K233952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date March 13, 2024
Days to Decision 89 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
1d slower than avg
Panel avg: 88d · This submission: 89d
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 K233952.
Tandem Mobi Insulin Pump with interoperable technology
K241078 · Tandem Diabetes Care, Inc. · Jul 2024
DEKA ACE Pump System
K241178 · Deka Research and Development · May 2024
Tandem Mobi insulin pump with interoperable technology
K240309 · Tandem Diabetes Care, Inc. · Mar 2024
Inessa System
K230545 · Triple Jump Israel , Ltd. · Dec 2023
t:slim X2 Insulin Pump with Interoperable Technology
K232380 · Tandem Diabetes Care, Inc. · Nov 2023
Omnipod 5 ACE Pump
K231826 · Insulet Corporation · Oct 2023