510(k) Report

FDA applicant

Femspec LLC

Port Townsend, WA4 decisions2004–20060 recalls

FDA records 4 decisions for Femspec LLC (Port Townsend, WA) from 2004 to 2006: 4 510(k) clearances. Most are in product codes HIB (Speculum, Vaginal, Nonmetal) and HHK (Curette, Suction, Endometrial (And Accessories)). Its devices cite 1 predicate, 0 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Femspec LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HIBSpeculum, Vaginal, Nonmetal2decisions
  • HHKCurette, Suction, Endometrial (And Accessories)1decision
  • PCFSampler, Endocervical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K060320Femecc Endocervical CuretteFemspec LLC · 20061cites it

What has FDA decided for it lately?

  • K060320Femecc Endocervical CuretteFemspec LLC · 2006
  • K052192Femspce-S Disposable Sterile Vaginal Speculum, Model ST-IFemspec LLC · 2006
  • K051294Femtest Endometrial Suction Curette, Model FT-1Femspec LLC · 2005
  • K041757Femspec Disposable Vaginal SpeculumFemspec LLC · 2004

All 4 as Femspec LLC →