510(k) Report

FDA applicant

Ypsomed AG

Burgdorf, CH12 decisions2010–20250 recalls

FDA records 12 decisions for Ypsomed AG (Burgdorf, CH) from 2010 to 2025: 12 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 252 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Ypsomed AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2010: 22012: 12013: 32015: 22016: 12017: 22025: 1
2010high 3 (2013) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Ypsomed AG by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen8decisions
  • FPASet, Administration, Intravascular2decisions
  • QOGInjection Data Capture Device1decision
  • KZHIntroducer, Syringe Needle1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 252 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 195 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130468Orbit Infusion SetYpsomed AG · 20132cite it
  • K152514Clickfine AutoProtect Pen NeedleYpsomed AG · 20152cite it
  • K102108Clickfine Pen NeedleYpsomed AG · 20102cite it
  • K100436Clickfine Pen NeedleYpsomed AG · 20101cites it
  • K131123Clickfine Autoprotect Pen NeedleYpsomed AG · 20131cites it
  • K131125Clickfine Pen NeedleYpsomed AG · 20131cites it

What has FDA decided for it lately?

  • K243901SmartPilot YpsoMate NS-A2.25Ypsomed AG · 2025
  • K171984Clickfine Pen Needle, Penfine Classic Pen NeedleYpsomed AG · 2017
  • K163400Orbit InserterYpsomed AG · 2017
  • K150921Orbit Infusion SetYpsomed AG · 2016
  • K152514Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
  • K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG · 2015
  • K131123Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
  • K131125Clickfine Pen NeedleYpsomed AG · 2013

All 12 as Ypsomed AG →