FDA applicant
Racal Health & Safety, Inc.
FDA records 3 decisions for Racal Health & Safety, Inc. (Frederick, MD) from 1988 to 1995: 3 510(k) clearances. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and HQY (Sunglasses (Non-Prescription Including…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Racal Health & Safety, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Racal Health & Safety, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Racal Health & Safety, 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) ReportOther applicant names beginning “Racal”
FDA records each applicant name separately; these may or may not be the same firm.