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

GDZ — Predicate Candidate Screening

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

21 daysmedian FDA review time

56 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K091462	SPECTRA MEDICAL SAFETY SCAPEL	Spectra, Inc.	2009-12-15	211
K890242	SCALPEL HANDLE	Kinetic Medical Products	1989-01-27	9
K884512	BEAVER(R) HANDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-11-17	21
K863951	P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE	Precision Surgical Industries, Inc.	1986-10-24	14
K863808	THE S. CORDERO STYLUS	S. Cordero Co.	1986-10-14	14
K863212	KEISEI HANDLES FOR SURGICAL BLADES	Keisei Medical Industrial Co., Ltd.	1986-09-02	13
K854858	SCALPEL HANDLE	Medelec Intl. Corp.	1985-12-24	19
K852735	SCALPEL HANDLE #7 SS 410 OR 420	The Huxley Instrument Corp.	1985-07-15	19
K852711	SCALPEL HANDLE #3 SS 410 OR 420	The Huxley Instrument Corp.	1985-07-15	19
K851750	7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7	Artiberia	1985-06-20	56
K852042	BRIMFIELD CANNULATED BLADE HOLDER	Brimfield Scientific Instruments	1985-06-11	33
K812876	SURGICAL PAWS	M-W Laboratories, Inc.	1981-11-20	37
K812814	ZEE SURGICAL INSTRUMENTS	Zee Medical Products Co., Inc.	1981-11-06	31
K812070	BORES* ADJUSTABLE BLADE HOLDER	Santa Barbara Medco, Inc.	1981-08-18	28
K810720	I.M. SCALPEL HANDLE	Instrument Makar, Inc.	1981-04-03	17
K761035	SURGICAL BLADE HANDLES	Parke-Davis Co.	1976-12-21	36

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