FDA applicant

Astral, Ltd.

Millersville, MD3 decisions1993–19950 recalls

FDA records 3 decisions for Astral, Ltd. (Millersville, MD) from 1993 to 1995: 3 510(k) clearances. Most are in product codes FMT (Warmer, Infant Radiant) and KMK (Device, Intravascular Catheter Securement). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Astral, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Astral”

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

Astral Medical Systems 4

Astral, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Astral”