510(k) Report

FDA applicant

Thinklabs, Inc.

Sound Beach, NY1 decision2003–20030 recalls

FDA records 1 decision for Thinklabs, Inc. (Sound Beach, NY) in 2003: 1 510(k) clearance. All are in product code DQD (Stethoscope, Electronic). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Thinklabs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Thinklabs, Inc.’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?

  • DQDStethoscope, Electronic1decision

What has FDA decided for it lately?

  • K032230Rhythm Digital Electronic StethoscopeThinklabs, Inc. · 2003

The one decision as Thinklabs, Inc. →