510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243901Substantially Equivalent

SmartPilot YpsoMate NS-A2.25

Ypsomed AG, Burgdorf, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243901 is the FDA 510(k) clearance record for SmartPilot YpsoMate NS-A2.25, a class II device, cleared for Ypsomed AG on under FDA product code QOG (Injection Data Capture Device). FDA's definition for product code QOG reads: "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...". FDA records list 12 510(k) clearances for Ypsomed AG, from to . As of , FDA records show no recalls naming K243901.

Clearance record

Decision date
Received
(252 days to decision)
Product code
QOG Injection Data Capture Device
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Ypsomed AG Brunnmattstrasse 6, Burgdorf, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QOG

Trailing 12 months

FDA records hold no clearances under product code QOG in the trailing twelve months.

FDA records show no clearances under product code QOG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QOG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260