510(k) Report

FDA applicant

Ron-Tech Medical, Ltd.

Petach-Tikva, IL2 decisions1999–20040 recalls

FDA records 2 decisions for Ron-Tech Medical, Ltd. (Petach-Tikva, IL) from 1999 to 2004: 2 510(k) clearances. All are in product code HDC (Tenaculum, Uterine). Its devices cite 1 predicate, 1 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 Ron-Tech Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ron-Tech Medical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ron-Tech Medical, 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?

  • HDCTenaculum, Uterine2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K992071Transvaginal Ultrasound Probe Holder DeviceRon-Tech Medical, Ltd. · 19992cite it

What has FDA decided for it lately?

  • K032585Transvaginal Ultrasound Probe Holder SystemRon-Tech Medical, Ltd. · 2004
  • K992071Transvaginal Ultrasound Probe Holder DeviceRon-Tech Medical, Ltd. · 1999

All 2 as Ron-Tech Medical, Ltd. →