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

DRR — Predicate Candidate Screening

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

31 daysmedian FDA review time

135 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K022660	BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117	Biocheck, Inc.	2002-12-19	132
K971570	EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391	Quinton Electrophysiology Corp.	1997-12-29	244
K925346	EP AMP, MODEL #901	Quinton Electrophysiology Corp.	1993-04-30	190
K914381	HORIZON 9000/HIS OPTION AMPLIFIER	Mennen Medical, Inc.	1992-01-28	117
K911935	CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED	Gould, Inc.	1991-07-22	82
K910307	CARDIOLAB AMPLIFIER MODULE (CAM)	Prucka Engineering, Inc.	1991-04-12	78
K894735	ASC-952 PHYSIOLOGICAL AMPLIFIER	Astro-Med, Inc.	1989-09-18	53
K894161	ASC-950 ECG AMPLIFIER	Astro-Med, Inc.	1989-08-03	50
K874441	BARD BIOPOTENTIAL AMPLIFIER	C.R. Bard, Inc.	1988-01-19	83
K853652	BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT	Fisher Imaging Corp.	1986-01-16	135
K813123	EPC FILTER	Codman & Shurtleff, Inc.	1981-11-27	23
K810828	NON-INVASIVE AMPLIFIER	Henry Ford Hospital	1981-04-10	17
K802686	HP MODEL 8880A FILTER	Hewlett-Packard Co.	1980-11-26	29
K802282	ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON	Consolidated Medical Equipment, Inc.	1980-10-10	21
K792283	ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON	Arzbaecher & Co.	1979-11-21	8
K791964	MODEL 15055A MAINFRAME	Hewlett-Packard Co.	1979-10-11	10
K790203	INTERVAL TIMER MODEL V4295	Electronics For Medicine, Inc.	1979-03-02	31
K780572	DCG PREAMPLIFIER MODULE	C-V Monitors Corp.	1978-05-09	29
K780043	ESIS MODULE	Datascope Corp.	1978-02-13	35
K772132	AMPLIFIER MODULE, 78211A ECG	Hewlett-Packard Co.	1977-11-22	8
K771976	ECG AMPLIFIER/R WAVE TRIGGER	G.D. Searle and Co.	1977-11-09	23
K771572	PATIENT MONITORS MODELS 78701A/78702A	Hewlett-Packard Co.	1977-08-30	15
K770243	ELGILOY STYLET	Cardiac Pacemakers, Inc.	1977-02-14	7
K761056	DISPLAY MONITOR (MODEL 78301A)	Hewlett-Packard Co.	1976-12-09	24

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