FDA applicant

Blackrock Microsystems

Salt Lake City, UT3 decisions2011–20210 recalls

FDA records 3 decisions for Blackrock Microsystems (Salt Lake City, UT) from 2011 to 2021: 3 510(k) clearances. Most are in product codes GZL (Electrode, Depth) and GYC (Electrode, Cortical). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Blackrock Microsystems, Inc.”.

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

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

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

FDA decisions per year

1in 2021

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Blackrock Microsystems by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blackrock Microsystems’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 “Blackrock”

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

Blackrock Neuromed 2

Blackrock Microsystems

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Blackrock”