510(k) Report

FDA applicant

Westmed, Inc.

Tucson, AZ8 decisions1995–20167 recalls

FDA records 8 decisions for Westmed, Inc. (Tucson, AZ) from 1995 to 2016: 8 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and CAP (Monitor, Airway Pressure (Includes Gauge…). Its devices cite 17 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2016

2007: 22008: 12012: 12014: 12015: 12016: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2014

2011: 5, 1 Class I2013: 12014: 1
2007high 5 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Westmed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Westmed”

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