Cleared Traditional

K243901 - SmartPilot YpsoMate NS-A2.25

K243901 is an FDA 510(k) clearance for SmartPilot YpsoMate NS-A2.25, manufactured by Ypsomed AG. The device is a Class 2 General Hospital device with product code QOG cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K243901 · Ypsomed AG · General Hospital
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Aug 2025
Decision
252d
Days
Class 2
Risk

K243901 is an FDA 510(k) clearance for the SmartPilot YpsoMate NS-A2.25. Classified as Injection Data Capture Device (product code QOG), Class II - Special Controls.

Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on August 28, 2025 after a review of 252 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ypsomed AG devices

FDA 510(k) Submission Details - K243901

510(k) Number K243901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2024
Decision Date August 28, 2025
Days to Decision 252 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 129d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QOG Device Classification - Class 2, Special Controls

Product Code QOG Injection Data Capture Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software.
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 General Hospital devices follow this clearance model.

Regulatory Peers - QOG Injection Data Capture Device

Devices cleared under the same product code (QOG) and FDA review panel - the closest regulatory comparables to K243901.
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