510(k) Report

FDA applicant

Instrumed, Inc.

Bothell, WA7 decisions1986–19954 recalls

FDA records 7 decisions for Instrumed, Inc. (Bothell, WA) from 1986 to 1995: 7 510(k) clearances. Most are in product codes KCY (Tourniquet, Pneumatic) and JTC (Device, Microtiter Diluting/Dispensing). 4 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Instrumed, Inc. since 2007.

Recalls per year

1in 2011

2010: 32011: 1
2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Instrumed, 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 “Instrumed”

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