FDA applicant

Prima, Inc.

Cleveland, TN19 decisions1994–19950 recalls

FDA records 19 decisions for Prima, Inc. (Cleveland, TN) from 1994 to 1995: 19 510(k) clearances. Most are in product codes CAI (Circuit, Breathing (W Connector, Adaptor, Y…) and BZO (Set, Tubing And Support, Ventilator (W Harness)). 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 Prima, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prima, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Prima, Inc.

Which product codes does it file in?

What has FDA decided for it lately?