FDA applicant

Quinton, Inc.

Seattle, WA164 decisions1976–20032 recalls

FDA records 164 decisions for Quinton, Inc. (Seattle, WA) from 1976 to 2003: 164 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DQY (Catheter, Percutaneous). Its devices cite 7 predicates, 3 of them its own earlier devices. 2 recalls are 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 Quinton, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quinton, Inc. since 2007.

Recalls per year

1in 2019

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Quinton, 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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Other applicant names beginning “Quinton”

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

Quinton Electrophysiology Corp. 3 Quinton Cardiology, Inc. 1

Quinton, Inc.

Which product codes does it file in?

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?

What has been recalled?

Other applicant names beginning “Quinton”