Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ypsomed AG — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

103 daysmedian FDA review time

358 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K243901	SmartPilot YpsoMate NS-A2.25	Ypsomed AG	2025-08-28	252
K171984	Clickfine Pen Needle, Penfine Classic Pen Needle	Ypsomed AG	2017-10-11	103
K163400	Orbit Inserter	Ypsomed AG	2017-07-26	233
K150921	Orbit Infusion Set	Ypsomed AG	2016-04-12	372
K152514	Clickfine AutoProtect Pen Needle	Ypsomed AG	2015-11-18	77
K150662	Clickfine Pen Needle, Penfine Classic Pen Needle (other trad	Ypsomed AG	2015-06-09	88
K131125	CLICKFINE PEN NEEDLE	Ypsomed AG	2013-07-05	74
K131123	CLICKFINE AUTOPROTECT PEN NEEDLE	Ypsomed AG	2013-07-05	74
K130468	ORBIT INFUSION SET	Ypsomed AG	2013-03-19	22
K110312	CLICKFINE AUTOPROTECT PEN NEEDLE	Ypsomed AG	2012-01-26	358
K102108	CLICKFINE PEN NEEDLE	Ypsomed AG	2010-11-23	119
K100436	CLICKFINE PEN NEEDLE	Ypsomed AG	2010-04-30	73

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda