510(k) Report

FDA applicant

Healthline Medical

Baldwin Park, CA1 decision1996–19960 recalls

FDA records 1 decision for Healthline Medical (Baldwin Park, CA) in 1996: 1 510(k) clearance. All are in product code CAF (Nebulizer (Direct Patient Interface)). 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 Healthline Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Healthline Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Healthline”

FDA records each applicant name separately; these may or may not be the same firm.