510(k) Report

FDA applicant

Femtek,Llc.

Rockville, MD3 decisions1996–20030 recalls

FDA records 3 decisions for Femtek,Llc. (Rockville, MD) from 1996 to 2003: 3 510(k) clearances. All are in product code LNW (Paper, Obstetric Ph). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Femtek, Inc.”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Femtek,Llc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Femtek,Llc.’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?

  • LNWPaper, Obstetric Ph3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K960648Phem-ChekFemtek, Inc. · 19962cite it
  • K012230Phem-AlertFemtek,Llc. · 20011cites it

What has FDA decided for it lately?

  • K032161Phem-AlertFemtek,Llc. · 2003
  • K012230Phem-AlertFemtek,Llc. · 2001
  • K960648Phem-ChekFemtek, Inc. · 1996

All 2 as Femtek,Llc. →The one decision as Femtek, Inc. →