Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HTR — Predicate Candidate Screening

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

16 daysmedian FDA review time

220 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K870349	BIODYNAMICS FEMORAL CANAL BRUSH #1201	Biodynamic Technologies, Inc.	1987-02-13	16
K870333	BIODYNAMICS SMALL JOINT BRUSH #1203	Biodynamic Technologies, Inc.	1987-02-13	16
K870329	ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202	Biodynamic Technologies, Inc.	1987-02-13	16
K813093	RICHARDS ACETABULAR BRUSH	Richard'S Medical Equip., Inc.	1981-11-20	18
K812506	THE ARTHROFILE	Dyonics, Inc.	1981-09-24	23
K780771	MICRO RASPS	Amsco Co.	1978-05-16	11
K771016	INTERMEDULLARY BRUSH	Howmedica Corp.	1978-01-12	220
K771745	RASPS FOR SCRAPING BONE	Depuy, Inc.	1977-09-28	13
K760109	PROSTHESIS, TOTAL HIP-RASP	Orthopedic Equipment Co., Inc.	1976-07-20	26

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