510(k) Report

FDA applicant

Medical Assemblies, Inc.

Bloomington, IN3 decisions1991–19910 recalls

FDA records 3 decisions for Medical Assemblies, Inc. (Bloomington, IN) in 1991: 3 510(k) clearances. Most are in product codes CAI (Circuit, Breathing (W Connector, Adaptor, Y…) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). 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 Medical Assemblies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Assemblies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Assemblies, 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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