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

JZT — Predicate Candidate Screening

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

51 daysmedian FDA review time

119 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K962499	ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER	Bartels, Inc.	1996-09-05	71
K883349	QLIA IMMUNOCHEMISTRY SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-09-07	29
K882677	STAT-20 FLUOROMETER	Weaver Medical	1988-07-12	14
K864699	FLUORESCENCE CONCENTRATION ANALYZER (FCA)	Pandex Laboratories, Inc.	1986-12-22	20
K863434	THE FIAX 5000 FLUOROMETER	Whittaker Bioproducts, Inc.	1986-10-29	55
K862674	PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM	Hybritech, Inc.	1986-08-15	32
K852240	SMS, SCREEN MACHINE SYSTEM	Pandex Laboratories, Inc.	1985-06-11	19
K842049	FLUOROSKAN	Flow Laboratories, Inc.	1984-12-03	195
K843356	FIAX 100 FLUOROMETER	Intl. Diagnostic Technology	1984-09-17	21
K834070	IMMPULSE SYSTEM	Paragon Diagnostics, Inc.	1984-03-23	119
K831870	ALLERGENETICS FLUORO-FAST READER	Axonics, Inc.	1983-08-12	63
K800698	AUTOFLUOR SYSTEM	California Immuno Diagnostic, Inc.	1980-05-28	61
K782150	FLUROMETER, DADE	Dade, Baxter Travenol Diagnostics, Inc.	1979-02-15	51
K770662	VIEWER, FLUOROMETIC, MODEL 721	Corning Medical & Scientific	1977-04-15	8

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