510(k) Report

FDA applicant

Knox Medical Diagnostics

San Francisco, CA2 decisions2020–20240 recalls

FDA records 2 decisions for Knox Medical Diagnostics (San Francisco, CA) from 2020 to 2024: 2 510(k) clearances. All are in product code BZH (Meter, Peak Flow, Spirometry). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Knox Medical Diagnostics, 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 Knox Medical Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Knox Medical Diagnostics by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Knox Medical Diagnostics’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 “Knox”

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