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

Alba-Waldensian, Inc. · Predicate Candidate Screening

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

31 daysmedian FDA review time
259 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K020592ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001Alba-Waldensian, Inc.2002-04-03400
K961405ALBA HEALTH PAS WRAP SYSTEMAlba-Waldensian, Inc.1996-12-262591
K852091ALBA DRY BURN PADAlba-Waldensian, Inc.1985-06-13310
K792357STERILE IMPERVIOUS ORTHOPEDIC STOCKINAlba-Waldensian, Inc.1979-12-18270
K781964COMPRESSION DEVICES, LIMBAlba-Waldensian, Inc.1978-12-12220
K780570TUBULAR DRESSING RETAINERAlba-Waldensian, Inc.1978-04-1990
K780547STERILE ORTHOPEDIC STOCKINETTEAlba-Waldensian, Inc.1978-04-1050
K771913HEEL/ELBOW PROTECTORAlba-Waldensian, Inc.1977-11-15350

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