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

KDG — Predicate Candidate Screening

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

28 daysmedian FDA review time

72 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K952678	STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT	Avail-Southwest Division	1995-07-10	28
K952200	OMNI-JUG	Waterstone Medical, Inc.	1995-06-29	50
K894785	SURGICAL CHISEL/OSTEOTOME	Fdt Precision Machine Co., Inc.	1989-08-18	22
K891471	SIL-MED WASTE FLUID DUMP BAG	Sil-Med Corp.	1989-08-15	153
K872947	POREX QUALITY PLASTIC SURGERY INSTRUMENTS	Porex Medical	1987-08-21	24
K872092	OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5	Military Engineering, Inc.	1987-06-23	22
K842824	CHERMEL BONE CHISELS	Cher Mel Corp.	1984-08-02	14
K772373	ANDERSON-NEIVERT OSTEOTOME	Edward Weck, Inc.	1978-03-09	72
K772376	NEIVERT OSTEOTOME	Edward Weck, Inc.	1978-03-09	72
K772374	SILVER OSTEOTOME	Edward Weck, Inc.	1978-03-09	72
K780135	CEMENT EXTRACTION INSTRUMENT SET	Orthopedic Equipment Co., Inc.	1978-01-31	7

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