510(k) Report

FDA applicant

Zuno Medical, Inc.

Campbell, CA1 decision2022–20220 recalls

FDA records 1 decision for Zuno Medical, Inc. (Campbell, CA) in 2022: 1 De Novo grant. All are in product code QJT (Rigid Sterilization Container With Software). No recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Zuno Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Zuno Medical, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zuno Medical, 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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