510(k) Report

FDA applicant

Black Diamond Video, Inc.

Richmond, CA2 decisions2014–20160 recalls

FDA records 2 decisions for Black Diamond Video, Inc. (Richmond, CA) from 2014 to 2016: 2 510(k) clearances. Most are in product codes ODA (Endoscopic Central Control Unit) and FTA (Light, Surgical, Accessories). 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 “Black Diamond Video”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Black Diamond Video, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Black Diamond Video, 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 “Black”

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