510(k) Report

FDA applicant

Olympic Medical Corp.

Seattle, WA37 decisions1978–20081 recall

FDA records 37 decisions for Olympic Medical Corp. (Seattle, WA) from 1978 to 2008: 37 510(k) clearances. Most are in product codes FRW (Scale, Patient) and LBI (Unit, Neonatal Phototherapy). Its devices cite 6 predicates, 3 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, general hospital panel, where it files most

How often FDA has decided Olympic Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Olympic Medical Corp.’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 “Olympic”

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