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

KHO · Predicate Candidate Screening

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

43 daysmedian FDA review time

182 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K112161	AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FL	Radiometer Medical Aps	2012-01-20	177	0
K973547	TRIAGE STATMETER	Biosite Incorporated	1998-01-13	117	0
K971103	AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM	Tosoh Medics, Inc.	1997-06-27	93	2
K962919	VITROS IMMUNODIAGNOSTIC SYSTEM	Johnson & Johnson Clinical Diagnostics, Inc.	1996-10-18	84	3
K952719	BIOCIRCUITS IOS (IN-OFFICE SYSTEM)	Biocircuits Corp.	1995-11-22	160	0
K950415	FLUOROSCAN NEONATAL	Isolab, Inc.	1995-09-05	217	0
K935047	AUTO DELFIA	Wallac OY	1994-05-23	214	0
K930689	AUTOBEAD THYROID UPTAKE	Bio-Chem Laboratory Systems, Inc.	1993-11-10	273	0
K926131	OPUS MAGNUM ANALYZER	Pb Diagnostic Systems, Inc.	1993-06-07	182	0
K923021	AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM	Tosoh Corp.	1992-07-21	28	0
K920888	MICROLITE MICROTITER PLATE LUMINOMETER ML2200	Dynatech Laboratories, Inc.	1992-03-19	37	0
K913130	STRATUS IINTELLECT IMMUNOASSAY SYSTEM	Baxter Healthcare Corp	1991-09-27	73	0
K901674	AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM	Tosoh Corp.	1990-05-02	22	0
K895240	DELFIA PLATE FLUOROMETER 1232	Pharmacia, Inc.	1989-10-04	44	0
K894159	OPUS IMMUNOASSAY SYSTEM	Pb Diagnostic Systems, Inc.	1989-08-03	50	0
K890908	STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES	Baxter Healthcare Corp	1989-03-24	29	0
K872803	CYBERFLUOR 615 IMMUNOANALYZER	Cyberfluor, Inc.	1987-09-02	49	0
K871550	PFI-20 POLARIZING FLUORIMETER	The Perkin-Elmer Corp.	1987-07-01	70	0
K860309	HEMAFLUOR REAGENT KIT	Helena Laboratories	1986-07-14	167	0
K851984	LKB-WALLAC 1230 ARCUS FLUOROMETER	Lkb Instruments, Inc.	1985-05-24	17	0
K830624	FLUOROMETER, GENERAL USE	Abbott Diagnostics	1983-04-05	36	0
K822942	INNOTRON FLUORIMETER SERIES ONE-10	Innotron of Oregon, Inc.	1982-12-09	66	0
K823112	CLINISTAT TDA SERIES	Miles Laboratories, Inc.	1982-11-29	39	0
K822772	MICROFLUOR READER	Dynatech Corp.	1982-10-27	43	0
K822701	FLUOROSTAT FLUOROMETER	Miles Laboratories, Inc.	1982-10-08	31	0
K813540	A FLUOROMETER	American Diagnostic Corp.	1981-12-31	10	0
K813146	SYVA ADVANCE TM FLUOROMETER	Syva Co.	1981-11-27	21	0
K811019	LKB 4460 FLUORIMETER	Lkb Instruments, Inc.	1981-04-29	14	0
K802579	CYBREX TM FPQ FLUORESCENE POLARIZATION	Abbott Laboratories	1980-11-12	23	0
K791329	FLUOROMATIC ANALYZER AND AUTOSAMPLER	Bio-Rad	1979-07-30	12	0
K790235	SPECTROPHOTOMETER MODEL 3000	The Perkin-Elmer Corp.	1979-03-15	42	0
K790236	SPECTROPHOTOMETER MODEL 650-40	The Perkin-Elmer Corp.	1979-03-15	42	0
K780242	SPECTROPHOTOMETER, FLUORESCENCE M.650-10	The Perkin-Elmer Corp.	1978-03-27	42	0
K780362	SPECTROFLUOROMETER SF-330	Varian Assoc., Inc.	1978-03-22	16	0
K780122	HTSH RIA	Abbott Laboratories	1978-02-03	11	0
K780031	FLUORESCENCE DETECTOR MODEL 420	Waters Assoc., Inc.	1978-01-20	11	0
K760506	HEMAFLOUR ZP	Buchler Instruments, Inc.	1976-10-28	66	0
K760261	DETECTOR, MODEL LC-100 FLUORESCENCE	The Perkin-Elmer Corp.	1976-09-27	70	0

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