510(k) Report

FDA applicant

Haselmeier GmbH

Farmington Hills, MI3 decisions2007–20090 recalls

FDA records 3 decisions for Haselmeier GmbH (Farmington Hills, MI) from 2007 to 2009: 3 510(k) clearances. All are in product code FMF (Syringe, Piston). Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Haselmeier Sarl”.

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 Haselmeier GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Haselmeier GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Haselmeier GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FMFSyringe, Piston3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070100Haselmeier PenHaselmeier Sarl · 20072cite it

What has FDA decided for it lately?

  • K083457TactipenHaselmeier GmbH · 2009
  • K082616Haselmeier Pen 8Haselmeier GmbH · 2008
  • K070100Haselmeier PenHaselmeier Sarl · 2007

All 2 as Haselmeier GmbH →The one decision as Haselmeier Sarl →