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

Arco Medical Products Co. — Predicate Candidate Screening

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

30 daysmedian FDA review time

87 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K802588	MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.	Arco Medical Products Co.	1980-11-19	30
K801806	EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE	Arco Medical Products Co.	1980-09-09	41
K801241	UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.	Arco Medical Products Co.	1980-06-30	34
K800837	PROGRAMMABLE BIPOLAR CARDIAC GENERATOR	Arco Medical Products Co.	1980-06-30	76
K800838	ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.	Arco Medical Products Co.	1980-06-04	50
K800326	ARCOLITH 3021-CARDIAC PULSE GENERATOR	Arco Medical Products Co.	1980-03-17	34
K792299	ARCOLITH 3020-CARDIAC PULSE GENERATOR	Arco Medical Products Co.	1979-11-29	15
K792216	ARCOLITH 2100-CARDIAC PULSE GENERATOR	Arco Medical Products Co.	1979-11-29	24
K791715	ARCOLITH 2000	Arco Medical Products Co.	1979-09-27	27
K791147	ARCO PROGAMMABLE PACEMAKER SYSTEM	Arco Medical Products Co.	1979-08-03	46
K791165	ARCOLITH 4000	Arco Medical Products Co.	1979-07-10	15
K790436	IMPLANTABLE HEART LEAD TERMINAL ADAPTER	Arco Medical Products Co.	1979-05-14	68
K790468	IMPLANTABLE HEART LEAD EXTENDER	Arco Medical Products Co.	1979-03-19	14
K782146	PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT	Arco Medical Products Co.	1978-12-27	0
K780776	ARCOBIOLITH PACEMAKER MODEL	Arco Medical Products Co.	1978-10-03	148
K780297	CARDIAC MINISCOPE & MINIGRAPH	Arco Medical Products Co.	1978-05-19	87
K780307	CARDIAC MINIGRAPH	Arco Medical Products Co.	1978-05-19	87
K771262	PACEMAKER & CARDIAC LEAD, BIPOLAR	Arco Medical Products Co.	1977-07-21	10
K770416	LEAD, HEART, BUTTERFLY CLAMP	Arco Medical Products Co.	1977-03-10	6
K761237	ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5	Arco Medical Products Co.	1976-12-21	8
K760963	DECUBITUS MATTRESS	Arco Medical Products Co.	1976-11-18	14

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