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

JZW — Predicate Candidate Screening

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

31 daysmedian FDA review time

73 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K001647	BN PROSPEC SYSTEM	Dade Behring, Inc.	2000-09-26	119
K761234	BEHRING LASER NEPHELOMETER	Behring Diagnostics, Inc.	1990-06-07	0
K892223	BEHRING NEPHELOMETER 100	Behring Diagnostics, Inc.	1989-05-04	31
K873401	TURBOX	Unipath , Ltd.	1987-09-23	30
K873407	RRT SYSTEM LASER REFLECTOMETER ANALYZER	Incstar Corp.	1987-09-23	29
K801949	BCM-302 COLLIMATING CONE & COMPENSATIN	B C Medical , Ltd.	1980-10-03	49
K801391	DISC 120 TRANSPORTER	Travenol Laboratories, S.A.	1980-07-14	31
K792014	LANCER L-INA BUFFER, POLYMER, WASH SOLU	Sherwood Medical Industries	1979-11-13	39
K781006	IMMUNOCHEMISTRY SYS. MANUAL MODE	Beckman Instruments, Inc.	1978-08-31	73
K761235	LASER STANDARD SERUM	Behring Diagnostics, Inc.	1976-12-30	20
K761236	ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.	Behring Diagnostics, Inc.	1976-12-30	20

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