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

Burdick Corp. — Predicate Candidate Screening

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

70 daysmedian FDA review time

298 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days
K942565	ALTAIR-DISC RECORDER	Burdick Corp.	1994-12-05	188
K941351	BURDICK PRO2 OXIMETER	Burdick Corp.	1994-10-13	205
K904032	ELITE II ELECTROCARDIOGRAPH	Burdick Corp.	1991-07-24	327
K903565	E560 ELECTROCARDIOGRAPH	Burdick Corp.	1991-07-24	351
K900729	NEOSERV 824	Burdick Corp.	1990-06-08	113
K885085	ERGOMED 840/ERGOMED 840L	Burdick Corp.	1989-10-03	298
K892835	E350 ELECTROCARDIOGRAPH	Burdick Corp.	1989-06-01	44
K883440	E550 ELECTROCARDIOGRAPH	Burdick Corp.	1989-01-17	155
K873774	M300 MONITOR/CONTROLLER T500 TREADMILL	Burdick Corp.	1987-11-06	51
K870920	ELITE ELECTROCARDIOGRAPH	Burdick Corp.	1987-04-13	38
K870880	EK10 ELECTROCARDIOGRAPH	Burdick Corp.	1987-04-09	36
K852250	595 ARRHYTHMIA MONITORING SYSTEM	Burdick Corp.	1986-05-02	344
K842944	MONITORING SYSTEM M720	Burdick Corp.	1985-03-01	219
K844665	COMPUTER	Burdick Corp.	1985-02-13	75
K840440	ELECTROCARDIOGRAPH E-340	Burdick Corp.	1984-08-03	184
K833951	E 310 ELECTROCARDIOGRAPH	Burdick Corp.	1984-05-09	176
K821755	TELCOR 2	Burdick Corp.	1982-07-02	17
K810940	THE BETA	Burdick Corp.	1981-07-16	100
K801944	MULTICHANNEL TELEMETRY SYSTEM	Burdick Corp.	1980-10-23	70
K801001	AMBULATORY MONITOR AM-1	Burdick Corp.	1980-05-28	33
K792371	TELEMETRY SYSTEM XMT-1 & REC-1	Burdick Corp.	1980-01-31	66
K792590	AP-1 AUTO PROGRAMMER	Burdick Corp.	1980-01-04	18
K790292	MONITOR, ELECTROCARDIOSCOPE	Burdick Corp.	1979-02-26	17
K790114	ELECTROCARDIOGRAPH, EK-9	Burdick Corp.	1979-02-08	17
K782059	TRANSMITTER, TR-1 ECG	Burdick Corp.	1978-12-21	14
K780702	CSS-60 DIGITAL HEART RATE METER	Burdick Corp.	1978-05-19	24
K780116	AMPLIFIER, PC-700	Burdick Corp.	1978-02-24	35
K780138	EK-670	Burdick Corp.	1978-02-17	23
K772152	CENTRAL MONITORING SYSTEM	Burdick Corp.	1977-11-28	13
K770239	DIGITAL HEART RATE METER	Burdick Corp.	1977-02-14	7
K770240	TREADMILL STRESS EXERCISE SYSTEM	Burdick Corp.	1977-02-14	7
K760857	TR-3 TRANSMITTER	Burdick Corp.	1977-01-28	105
K760271	ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)	Burdick Corp.	1976-11-15	116
K760268	ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.	Burdick Corp.	1976-11-12	113
K760272	CIRCUIT, PRINTED, SERVO-MECHANISM	Burdick Corp.	1976-11-12	113
K760266	MONITOR, ELECTROCARDIOSCOPE	Burdick Corp.	1976-10-13	83
K760265	ELCTROCARDIOGRAPH, EK-6	Burdick Corp.	1976-08-23	32
K760275	TREADMILL (TMS-300)	Burdick Corp.	1976-08-11	20

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