Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Alba Health Care — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

49 daysmedian FDA review time
91 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K864689ALBA HEALTH CARE IODOFORM PACKING STRIPAlba Health Care1987-01-20490
K861154ALBA HEALTH CARE PLAIN PACKING STRIPAlba Health Care1986-04-15180
K851918INFANT PHOTOTHERAPY MASKAlba Health Care1985-06-07360
K850904ALBA DRY BURN DRESSINGAlba Health Care1985-04-17430
K850881ALBA DRY BURN PADAlba Health Care1985-04-17440
K850241ALBA HEALTH CARE NON-ADHERING DRESSINGAlba Health Care1985-03-12490
K812904STERILE ORTHOPEDIC STOCKINETTEAlba Health Care1982-01-18910
K803171PROCEDURE & RECOVERY PATIENT SUITAlba Health Care1981-03-04790

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda