FDA applicant

Quantel Medical

Hot Springs, AR33 decisions2000–20260 recalls

FDA records 33 decisions for Quantel Medical (Hot Springs, AR) from 2000 to 2026: 33 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 75 for FDA’s reviews in the same codes and years. Its devices cite 75 predicates, 18 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Quantel Medical S.A.”, “Quantel Medical, Inc.”.

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

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

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

FDA decisions per year

1in 2024

2007high 3 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Quantel Medical’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 “Quantel”

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

Quantel S.A. 2 Quantel Derma GmbH 2

Quantel Medical

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Quantel”