510(k) Report

FDA applicant

Xsirius Medical, Inc.

Rolling Hills Estates, CA1 decision1986–19860 recalls

FDA records 1 decision for Xsirius Medical, Inc. (Rolling Hills Estates, CA) in 1986: 1 510(k) clearance. All are in product code KDT (Container, Specimen Mailer And Storage, Sterile). 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, pathology panel, where it files most

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

FDA decisions per year

No FDA decision for Xsirius Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Xsirius”

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