510(k) Report

FDA applicant

G. Dundas Co.

Black Diamond, WA4 decisions1980–20110 recalls

FDA records 4 decisions for G. Dundas Co. (Black Diamond, WA) from 1980 to 2011: 4 510(k) clearances. Most are in product codes CBN (Apparatus, Gas-Scavenging) and BSZ (Gas-Machine, Anesthesia). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “G. Dundas Co.,Inc.”.

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 G. Dundas Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like G. Dundas Co.’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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