510(k) Report

FDA applicant

Rapid Medical, Ltd.

Yokneam, IL12 decisions2019–20260 recalls

FDA records 12 decisions for Rapid Medical, Ltd. (Yokneam, IL) from 2019 to 2026: 10 510(k) clearances and 2 De Novo grants. Most are in product codes NRY (Catheter, Thrombus Retriever) and MOF (Guide, Wire, Catheter, Neurovasculature). Since 2016 its 510(k)s took a median of 171 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Rapid-Medical , Ltd.”, “Rapid Medical Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2019: 12020: 12021: 12022: 12023: 12024: 22025: 12026 (partial year): 4
2019high 4 (2026) · low 1 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Rapid Medical, Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rapid 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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Other applicant names beginning “Rapid”

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