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

FZS — Predicate Candidate Screening

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

29 daysmedian FDA review time

111 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K932493	SURGICAL CURETTE	Whitney Products, Inc.	1994-01-07	228
K902000	KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD	Kevtek Medical Products, Inc.	1990-08-21	111
K892521	CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE	Cymed, Inc.	1989-05-01	20
K891888	CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER	Zinnanti Surgical Instruments, Inc.	1989-04-12	19
K891334	ACU-CURETTE	Acuderm, Inc.	1989-04-11	32
K890366	ADENOID CURETTE	Kinetic Medical Products	1989-02-03	11
K875292	MICRODISCECTOMY CURETTE SET	T. Korossurgical Instruments Corp.	1988-01-29	30
K871925	STRAIGHT CUP CURRETTE, 1.7MM	Arthropedics, Inc.	1987-06-01	14
K854888	RANDALL CURETTE	Euro-Med Intl.	1985-12-24	18
K854899	NOVAK CURETTE	Euro-Med Intl.	1985-12-24	18
K842701	HOPPENSTEIN MICROSURGICAL SPINAL INSTRU	Downs Surgical , Ltd.	1984-08-02	22
K831367	PMN VOLZ CURETTES	3M Company	1983-05-25	29
K831119	LUO CURRETTES #3211	Pmt, Inc.	1983-05-09	34
K803178	ANSPACH MENISECTOMY KNIFE	The Anspach Effort, Inc.	1981-02-13	59

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