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

Biotronik Sales, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time

254 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days
K875199	NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR	Biotronik Sales, Inc.	1988-02-18	62
K853194	ERA-20	Biotronik Sales, Inc.	1987-03-11	589
K860036	EDP-20 PACEMAKER	Biotronik Sales, Inc.	1987-01-12	371
K863879	NEOS-M VS-1 PULSE GENERATOR	Biotronik Sales, Inc.	1986-12-10	65
K863878	TRIOS-M VS-1 PULSE GENERATOR	Biotronik Sales, Inc.	1986-12-10	65
K863480	BIOTRONIK PERMANENT PACEMAKER ELECTRODE	Biotronik Sales, Inc.	1986-09-23	14
K860921	NEOS VS-1, PULSE GENERATOR	Biotronik Sales, Inc.	1986-08-08	150
K860922	MIKROS, MIKROS VS-1, PULSE GENERATOR	Biotronik Sales, Inc.	1986-08-04	146
K853567	DJP UNIPOLAR	Biotronik Sales, Inc.	1986-05-07	254
K853566	DJ UNIPOLAR	Biotronik Sales, Inc.	1986-05-07	254
K853568	DNR UNIPOLAR	Biotronik Sales, Inc.	1986-01-15	142
K853058	NEOS - M ABP	Biotronik Sales, Inc.	1985-09-13	56
K853057	TRIOS - M	Biotronik Sales, Inc.	1985-09-12	55
K844842	NEOS-LP PULSE GENERATOR	Biotronik Sales, Inc.	1985-04-18	127
K844795	NEOS-M PULSE GENERATOR	Biotronik Sales, Inc.	1985-04-18	129
K844812	NEOS - PULSE GENERATOR	Biotronik Sales, Inc.	1985-04-18	128
K844794	LEPTOS PULSE GENERATOR	Biotronik Sales, Inc.	1985-04-18	129
K844841	KALOS-04 PULSE GENERATOR	Biotronik Sales, Inc.	1985-04-18	127
K841450	BIOTRONIK DNP UNIPOLAR	Biotronik Sales, Inc.	1985-02-07	304
K841451	BIOTRONIK DY-UNIPOLAR	Biotronik Sales, Inc.	1985-02-07	304
K841633	NEOS LP	Biotronik Sales, Inc.	1984-08-06	109
K841635	LEPTOS	Biotronik Sales, Inc.	1984-08-03	106
K841950	PULSE GENERATOR KALOS-04	Biotronik Sales, Inc.	1984-06-25	52
K841636	NEOS M	Biotronik Sales, Inc.	1984-06-25	67
K833106	BIOTRONIK DFH UNIPOLAR PE-60/4-DFH	Biotronik Sales, Inc.	1983-10-20	38
K833099	BIOTRONIK N, BIPOLAR PEB-60/4-N	Biotronik Sales, Inc.	1983-10-20	38
K833098	BIOTRONIK DN UNIPOLAR PE-60/4-DN &	Biotronik Sales, Inc.	1983-10-19	37
K833104	BIOTRONIK D2K UNIPOLAR PE-60/4	Biotronik Sales, Inc.	1983-10-19	37
K833101	BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC	Biotronik Sales, Inc.	1983-10-19	37
K833108	BIOTRONIK I-UNIPOLAR PE-60/2-13	Biotronik Sales, Inc.	1983-10-19	37
K830862	NEDS-01 & EPR-500	Biotronik Sales, Inc.	1983-05-25	68
K822907	KALOS-03 BIPOLAR	Biotronik Sales, Inc.	1982-11-01	32
K821073	PULSE GENERATOR	Biotronik Sales, Inc.	1982-05-07	21
K820774	IMPLANTABLE, MULTIPROGRAMMABLE	Biotronik Sales, Inc.	1982-04-09	17
K812218	KALOS-03	Biotronik Sales, Inc.	1981-10-13	68
K810494	TYPE FH ENDOCARDIAL LEAD	Biotronik Sales, Inc.	1981-08-07	164
K810491	TYPE YC ENDOCARDIAL LEAD	Biotronik Sales, Inc.	1981-03-20	24
K810492	TYPE YR ENDOCARDIAL LEAD	Biotronik Sales, Inc.	1981-03-20	24
K810493	TYPE N ENDOCARDIAL LEAD	Biotronik Sales, Inc.	1981-03-20	24
K800376	EPR-200 PROGRAMMER MODEL 010	Biotronik Sales, Inc.	1980-04-21	60
K800375	NOMOS-01 PULSE GENERATOR	Biotronik Sales, Inc.	1980-04-16	55

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