Cleared Traditional

K252104 - T1D1 (FDA 510(k) Clearance)

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

K252104 · Comerge AG · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
48d
Days
Class 2
Risk

K252104 is an FDA 510(k) clearance for the T1D1. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Comerge AG (Zurich, CH). The FDA issued a Cleared decision on August 20, 2025 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 868.1890 - 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 Comerge AG devices

Submission Details

510(k) Number K252104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2025
Decision Date August 20, 2025
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - NDC Calculator, Drug Dose

All 53
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K252104.
EndoTool IV Cloud 1.0
K260910 · Glooko, Inc. · May 2026
MiniMed Go App
K253512 · Medtronic Minimed · Jan 2026
UpDoc
K253281 · Updoc, Inc. · Dec 2025
EndoTool IV (3.1)
K241088 · Monarch Medical Technologies · Dec 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775 · Medtronic Minimed · Nov 2024
iSage Rx
K242066 · Amalgam Rx, Inc. · Aug 2024