510(k) Report

FDA applicant

Rovers Medical Devices B.V.

Pasadena, CA3 decisions2000–20050 recalls

FDA records 3 decisions for Rovers Medical Devices B.V. (Pasadena, CA) from 2000 to 2005: 3 510(k) clearances. All are in product code HHT (Spatula, Cervical, Cytological). 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 Rovers Medical Devices B.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rovers Medical Devices B.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rovers Medical Devices B.V. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • HHTSpatula, Cervical, Cytological3decisions

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.

  • K002520Rovers SpatulaRovers Medical Devices B.V. · 20001cites it

What has FDA decided for it lately?

  • K043369Cervex-Brush CombiRovers Medical Devices B.V. · 2005
  • K002520Rovers SpatulaRovers Medical Devices B.V. · 2000
  • K001119Rovers Endocervex-BrushRovers Medical Devices B.V. · 2000

All 3 as Rovers Medical Devices B.V. →

Other applicant names beginning “Rovers”

FDA records each applicant name separately; these may or may not be the same firm.

Rovers Diagnostic Devices 3Rovers B.V. 2