FDA applicant

Quinton Cardiology, Inc.

Bothell, WA1 decision2004–20041 recall

FDA records 1 decision for Quinton Cardiology, Inc. (Bothell, WA) in 2004: 1 510(k) clearance. All are in product code MHX (Monitor, Physiological, Patient (With…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Quinton Cardiology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quinton Cardiology, Inc. since 2007.

Recalls per year

1in 2020

2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Quinton Cardiology, 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, Inc. 164 Quinton Electrophysiology Corp. 3

Quinton Cardiology, 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”