510(k) Report

FDA applicant

Facet Technologies, LLC

Atlanta, GA8 decisions2014–20240 recalls

FDA records 8 decisions for Facet Technologies, LLC (Atlanta, GA) from 2014 to 2024: 8 510(k) clearances. Most are in product codes QRL (Multiple Use Blood Lancet For Single Patient…) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Facet Technologies”.

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 Facet Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014: 32022: 32023: 12024: 1
2014high 3 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Facet Technologies, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Facet Technologies, LLC’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 “Facet”

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