FDA applicant
Allegiance Healthcare Corp.
FDA records 64 decisions for Allegiance Healthcare Corp. (Mcgraw Park, IL) from 1996 to 2003: 64 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and KGO (Surgeon'S Gloves). Its devices cite 12 predicates, 3 of them its own earlier devices. 34 recalls are linked to its devices.
FDA’s records also spell it “Allegiance Healthcare Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Allegiance Healthcare Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Allegiance Healthcare Corp. since 2007.
Recalls per year
10in 2021
Class I Class II/III not classified
Planning a device like Allegiance Healthcare Corp.’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 “Allegiance”
FDA records each applicant name separately; these may or may not be the same firm.