Atlas FDA

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

ILG — Predicate Candidate Screening

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

13 daysmedian FDA review time
32 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K833437ORTHOPEDIC STOCKINETTENorthern Medical Surgical, Inc.1983-11-03290
K831540COMPRESSOGRIP ELASTIC STUMP SHRINKER#Fred Sammons, Inc.1983-06-08270
K780612STOCKINETTE, STERILEAbco Dealers, Inc.1978-04-1990
K780547STERILE ORTHOPEDIC STOCKINETTEAlba-Waldensian, Inc.1978-04-1050
K770346ORTHOPEDIC STOCKINETTEConvertors1977-03-07130
K770173STOCKINETTEChase Mfg. Co.1977-02-08130
K760817ORTHOPEDIC TUBULAR STOCKINETTEParke-Davis Co.1976-10-2080
K760576TOURNIWRAP BANDAGERichard'S Medical Equip., Inc.1976-10-05320

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