510(k) Report

FDA applicant

Multispiro, Inc.

Irvine, CA3 decisions1992–19920 recalls

FDA records 3 decisions for Multispiro, Inc. (Irvine, CA) in 1992: 3 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BZC (Calculator, Pulmonary Function Data). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Multispiro, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Multispiro, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Multispiro, 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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