510(k) Report

FDA applicant

Corventis, Inc.

St. Paul, MN7 decisions2009–20140 recalls

FDA records 7 decisions for Corventis, Inc. (St. Paul, MN) from 2009 to 2014: 7 510(k) clearances. Most are in product codes QYX (Outpatient Cardiac Telemetry) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 20 predicates, 10 of them its own earlier devices. 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 Corventis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 32011: 12012: 22014: 1
2009high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Corventis, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Corventis, 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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