FDA applicant

Astral Medical Systems

Buena Park, CA4 decisions1985–19900 recalls

FDA records 4 decisions for Astral Medical Systems (Buena Park, CA) from 1985 to 1990: 4 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and JQT (Densitometer/Scanner (Integrating…). 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, hematology panel, where it files most

How often FDA has decided Astral Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Astral Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Astral Medical Systems’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

Other applicant names beginning “Astral”

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

Astral, Ltd. 3

Astral Medical Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Astral”