510(k) Report

FDA applicant

Verathon Incorporated

Bothell, WA5 decisions2007–20176 recalls

FDA records 5 decisions for Verathon Incorporated (Bothell, WA) from 2007 to 2017: 5 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 7 predicates, 4 of them its own earlier devices. 6 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, radiology panel, where it files most

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

FDA decisions per year

1in 2017

2007: 12008: 12009: 12015: 12017: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2020

2009: 12010: 32015: 12020: 1
2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Verathon Incorporated’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 “Verathon”

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