FDA applicant

Accurate Medical Therapeutics, Ltd.

Rehovot, IL4 decisions2018–20230 recalls

FDA records 4 decisions for Accurate Medical Therapeutics, Ltd. (Rehovot, IL) from 2018 to 2023: 4 510(k) clearances. All are in product code DQO (Catheter, Intravascular, Diagnostic). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 52 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Accurate Medical Therapeutics”.

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 Accurate Medical Therapeutics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018high 2 (2020) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Accurate Medical Therapeutics, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Accurate Medical Therapeutics, Ltd.’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

Other applicant names beginning “Accurate”

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

Accurate Surgical Instruments Co. 9 Accurate Meditech, Inc. 2 Accurate Medical Devices, Inc. 1 Accurate Access, LLC 1

Accurate Medical Therapeutics, Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Accurate”