510(k) Report

FDA applicant

Rovers Diagnostic Devices

Nyack, NY3 decisions1994–19950 recalls

FDA records 3 decisions for Rovers Diagnostic Devices (Nyack, NY) from 1994 to 1995: 3 510(k) clearances. Most are in product codes HHT (Spatula, Cervical, Cytological) and FDX (Endoscopic Cytology Brush). 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 Diagnostic Devices’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rovers Diagnostic Devices since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rovers Diagnostic Devices’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, Cytological2decisions
  • FDXEndoscopic Cytology Brush1decision

What has FDA decided for it lately?

  • K941472Cervex-Brush Pap KitRovers Diagnostic Devices · 1995
  • K942843Cervex-Brush (R), Sterile, Spatula, Cervical, CytologyRovers Diagnostic Devices · 1994
  • K942144Urethra-BrushRovers Diagnostic Devices · 1994

All 3 as Rovers Diagnostic Devices →

Other applicant names beginning “Rovers”

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

Rovers Medical Devices B.V. 3Rovers B.V. 2