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

Cardiac Pacemakers, Inc. · Predicate Candidate Screening

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

46 daysmedian FDA review time

101 days90th percentile

76clearances measured

K-number	Device	Applicant	Decided	Review days
K093969	ACUITY BREAK-AWAY GUIDE CATHETER	Cardiac Pacemakers, Inc.	2010-03-05	72
K080154	ACUITY UNIVERSAL CUTTER	Cardiac Pacemakers, Inc.	2008-03-20	57
K934727	REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER	Cardiac Pacemakers, Inc.	1994-01-10	101
K920601	ASTRA T2, ASTRA T4, ASTRA T6	Cardiac Pacemakers, Inc.	1992-10-28	260
K912379	PDT CARRYALL TRANSMITTER, VARIOUS MODELS	Cardiac Pacemakers, Inc.	1991-06-17	19
K905674	LEAD STYLET	Cardiac Pacemakers, Inc.	1991-01-30	43
K900498	MODIFIED BETATRON IV INSULIN INFUSION SYSTEM	Cardiac Pacemakers, Inc.	1990-02-23	36
K894738	MODEL 6888 LEAD TUNNELER	Cardiac Pacemakers, Inc.	1989-09-13	48
K890785	ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE	Cardiac Pacemakers, Inc.	1989-03-10	23
K875147	TORQUE HEX WRENCH	Cardiac Pacemakers, Inc.	1988-01-27	43
K872774	BETATRON IV SYSTEM	Cardiac Pacemakers, Inc.	1988-01-05	175
K865013	ASTRA T2, T4 AND T6	Cardiac Pacemakers, Inc.	1987-02-19	58
K863046	ULTRA SOFTWARE MODULE: MODEL 2016	Cardiac Pacemakers, Inc.	1986-12-05	115
K863045	PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580	Cardiac Pacemakers, Inc.	1986-09-29	48
K863000	ASTRA 2,3,4 AND 6: CHIP REVISION	Cardiac Pacemakers, Inc.	1986-08-19	11
K860585	ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR	Cardiac Pacemakers, Inc.	1986-07-16	148
K860584	SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN	Cardiac Pacemakers, Inc.	1986-06-06	108
K855171	TELEMETRY WAND MODEL	Cardiac Pacemakers, Inc.	1986-01-22	27
K852060	INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123	Cardiac Pacemakers, Inc.	1985-06-07	29
K842394	ASTRA 2, ASTRA 3, 4 & 6	Cardiac Pacemakers, Inc.	1984-10-17	120
K842364	HANDHELD PACEMAKER PROGRAMMER & SOFTWAR	Cardiac Pacemakers, Inc.	1984-09-24	98
K843060	SENTRA	Cardiac Pacemakers, Inc.	1984-09-20	48
K833306	BETATRON I AMBULATORY INSULIN PUMP	Cardiac Pacemakers, Inc.	1983-11-28	66
K831216	COMMAND ULTRA II	Cardiac Pacemakers, Inc.	1983-07-12	89
K831161	COMMAND ULTRA I	Cardiac Pacemakers, Inc.	1983-06-15	65
K831160	LEAD ADAPTERS #'S 6016,6022,6017 ETC	Cardiac Pacemakers, Inc.	1983-05-09	28
K831259	RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE	Cardiac Pacemakers, Inc.	1983-05-09	21
K830382	COMMAND ULTRA II	Cardiac Pacemakers, Inc.	1983-03-17	41
K822857	CPI PRINTER	Cardiac Pacemakers, Inc.	1983-01-08	103
K823204	BETATRON II	Cardiac Pacemakers, Inc.	1982-11-30	34
K822775	INFUS. SETS-9120-50 CM & 9121-100 CM,EXT	Cardiac Pacemakers, Inc.	1982-11-03	50
K822774	9110 SYRINGE	Cardiac Pacemakers, Inc.	1982-11-03	50
K822776	TEFLON CANNULA	Cardiac Pacemakers, Inc.	1982-11-03	50
K822309	COMMAND NP	Cardiac Pacemakers, Inc.	1982-10-04	62
K820230	PACEMAKER PROGRAMMER 2030	Cardiac Pacemakers, Inc.	1982-03-15	46
K820231	COMMAND ULTRA I	Cardiac Pacemakers, Inc.	1982-03-15	46
K820073	OPEN LOOP AMBULATORY INSULIN INFUSION	Cardiac Pacemakers, Inc.	1982-01-25	13
K813534	COMMAND P5	Cardiac Pacemakers, Inc.	1982-01-22	36
K812917	PORTABLE LIDOCAINE INFUSION PUMP	Cardiac Pacemakers, Inc.	1981-11-06	18
K811402	COMMAND P5(BIPOLAR PULSE GENERATOR)	Cardiac Pacemakers, Inc.	1981-07-27	70
K811401	COMMAND P5(UNIPOLAR PULSE GENERATOR)	Cardiac Pacemakers, Inc.	1981-07-27	69
K811217	PACEMAKER PROGRAMMER #2010	Cardiac Pacemakers, Inc.	1981-07-20	77
K811774	OPEN LOOP AMBULATORY INFUSION DEVICE	Cardiac Pacemakers, Inc.	1981-07-10	17
K802353	MICRO THIN-PII, #0523	Cardiac Pacemakers, Inc.	1980-12-22	88
K803034	MICROTHIN-PII BIPOLAR PULSE GEN. #0623	Cardiac Pacemakers, Inc.	1980-12-22	21
K803035	MICROTHIN-PII BIPOLAR PULSE GEN. #0621	Cardiac Pacemakers, Inc.	1980-12-22	21
K802352	MICRO THIN-DII, #0521	Cardiac Pacemakers, Inc.	1980-12-22	88
K802058	MAPPING PROBE MODEL #6540	Cardiac Pacemakers, Inc.	1980-11-19	86
K802409	MICROTHIN-DI BIPOLAR PULSE GENERATOR	Cardiac Pacemakers, Inc.	1980-10-31	28
K802410	MICROTHIN-PI BIPOLAR PULSE GENERATOR	Cardiac Pacemakers, Inc.	1980-10-31	28

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