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

KZR — Predicate Candidate Screening

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

45 daysmedian FDA review time

60 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K973074	2487 DUAL WAVELENGTH ABSORBANCE DETECTOR	Waters Corporation	1997-10-06	49
K931227	USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000	U.S. Drug Testing, Inc.	1993-05-06	57
K905538	COLUMNS LIQUID CHROMATOGRAPHY DPM	Millpore Corp.	1991-01-25	45
K861392	SYVA SOLID PHASE COLUMNS SYSTEM II	Syva Co.	1986-06-13	60
K860197	SERIES 410 LC PUMP	The Perkin-Elmer Corp.	1986-03-17	54
K851945	VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM	Varian Assoc., Inc.	1985-05-24	21
K843568	LIQUID CHROMATOGRAPH 400	The Perkin-Elmer Corp.	1984-11-20	71
K841890	VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY	Varian Assoc., Inc.	1984-06-14	38
K840977	LIQUID CHROMATOGRAPHIC DETECTOR LC-95	The Perkin-Elmer Corp.	1984-04-19	44
K832201	CHROM-PREP	Hamilton Co.	1983-08-16	40
K802725	VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS	Varian Assoc., Inc.	1980-12-11	41
K780944	LIQUID CHROMATOGRAPH MODEL 850	E.I. Dupont DE Nemours & Co., Inc.	1978-07-27	49
K780945	LIQUID CHROMATOGRAPH MODEL 860	E.I. Dupont DE Nemours & Co., Inc.	1978-07-27	49
K770255	LC-65T DETECTOR AND OVEN	The Perkin-Elmer Corp.	1977-02-25	15
K770254	CHROMATOGRAPH, SERIES 3, LIQUID	The Perkin-Elmer Corp.	1977-02-24	14

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