FDA applicant

Pneumocare, Inc.

Laguna Niguel, CA1 decision1998–19980 recalls

FDA records 1 decision for Pneumocare, Inc. (Laguna Niguel, CA) in 1998: 1 510(k) clearance. All are in product code JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Pneumocare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pneumocare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pneumocare, Inc.’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

Pneumocare, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?