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

Clinical Data, Inc. — Predicate Candidate Screening

36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

41 daysmedian FDA review time

150 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K071706	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIB	Clinical Data, Inc.	2007-12-20	182
K052591	NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT	Clinical Data, Inc.	2006-02-09	141
K033983	VITALAB IRON REAGENT	Clinical Data, Inc.	2004-05-21	150
K040631	VITALAB DIRECT BILIRUBIN REAGENT	Clinical Data, Inc.	2004-03-18	8
K040534	VITALAB AMYLASE REAGENT	Clinical Data, Inc.	2004-03-11	9
K034000	VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR	Clinical Data, Inc.	2004-03-10	77
K040467	VITALAB URIC ACID REAGENT	Clinical Data, Inc.	2004-03-08	13
K040508	VITALAB MAGNESIUM REAGENT	Clinical Data, Inc.	2004-03-08	10
K031042	ATAC HEMOGLOBIN A1C REAGENT KIT	Clinical Data, Inc.	2003-11-03	216
K031044	ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR	Clinical Data, Inc.	2003-07-15	105
K863904	DISPOSABLE ECG MONITORING ELECTRODE	Clinical Data, Inc.	1987-01-06	91
K860047	DETERMINATION OF CARBAMAZEPINE	Clinical Data, Inc.	1986-01-22	16
K860045	DETERMINATION OF GENTAMICIN	Clinical Data, Inc.	1986-01-22	16
K860046	DETERMINATION OF PHENOBARBITAL	Clinical Data, Inc.	1986-01-22	16
K860049	DETERMINATION OF QUINIDINE	Clinical Data, Inc.	1986-01-22	16
K860048	DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)	Clinical Data, Inc.	1986-01-22	16
K854186	IN VITRO TEST DETERMINATION OF SGPT(ALT)	Clinical Data, Inc.	1985-12-25	71
K854183	IN VITRO TEST DETERMINATION OF THEOPHYLLINE	Clinical Data, Inc.	1985-12-19	65
K854184	IN-VITRO TEST DETERMINATION OF TOBRAMYCIN	Clinical Data, Inc.	1985-12-04	50
K854180	IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN	Clinical Data, Inc.	1985-11-25	41
K854178	IN-VITRO TEST FOR THE DETERMINATION OF CREATININE	Clinical Data, Inc.	1985-11-25	41
K854181	IN-VITRO TEST DETERMINATION OF ALBUMIN	Clinical Data, Inc.	1985-11-25	41
K854185	IN-VITRO TEST DETERMINATION OF URIC ACID	Clinical Data, Inc.	1985-11-25	41
K854182	IN-VITRO TEST DETERMINATION OF TRIALYCERIDE	Clinical Data, Inc.	1985-11-25	41
K854179	IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL	Clinical Data, Inc.	1985-11-25	41
K854188	IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO	Clinical Data, Inc.	1985-11-25	41
K854187	IN-VITRO TEST DETERMINATION OF SGOT (AST)	Clinical Data, Inc.	1985-11-25	41
K854177	IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE	Clinical Data, Inc.	1985-11-25	41
K851889	CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY	Clinical Data, Inc.	1985-10-23	176
K852441	IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN	Clinical Data, Inc.	1985-08-21	72
K852177	FOAM ECG ELECTRODES	Clinical Data, Inc.	1985-08-09	81
K850392	INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS	Clinical Data, Inc.	1985-04-12	70
K823529	FULL-DISCLOSURE AMBULATORY ECG SYSTEM	Clinical Data, Inc.	1982-12-15	22
K822432	CENTURION CHART RECORDER	Clinical Data, Inc.	1982-11-01	81
K821802	CENTURION ELECTRODE BELT	Clinical Data, Inc.	1982-07-30	45
K821721	CLINICAL DATA APNEA DETECTOR	Clinical Data, Inc.	1982-07-13	33

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