510(k) Report

FDA applicant

Femcare, Ltd.

Romsey3 decisions1988–19960 recalls

FDA records 3 decisions for Femcare, Ltd. (Romsey) from 1988 to 1996: 2 510(k) clearances and 1 original PMA approval. Most are in product codes KNH (Laparoscopic Contraceptive Tubal Occlusion…) and KOB (Catheter, Suprapubic (And Accessories)). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Femcare, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Femcare, Ltd.’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?

  • KNHLaparoscopic Contraceptive Tubal Occlusion Device1decision
  • KOBCatheter, Suprapubic (And Accessories)1decision
  • KOASurgical Instruments, G-U, Manual (And Accessories)1decision

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.

  • K884061Add-a-CathFemcare, Ltd. · 19881cites it

What has FDA decided for it lately?

  • P920046Filshie Clip (Mark VI) SystemFemcare, Ltd. · 1996
  • K932465LI VasectomyFemcare, Ltd. · 1994
  • K884061Add-a-CathFemcare, Ltd. · 1988

All 3 as Femcare, Ltd. →