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

Vitatron Medical BV — Predicate Candidate Screening

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

64 daysmedian FDA review time

247 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K854790	CERYX PACEMAKER MODELS 114, 314 & 614	Vitatron Medical BV	1986-08-28	272
K844484	HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA	Vitatron Medical BV	1985-07-24	247
K844485	CERYX6, 611, CERYX 3 311 & CERYX 1 111	Vitatron Medical BV	1985-04-19	151
K844483	TP 1	Vitatron Medical BV	1985-04-19	151
K840668	ELECTRODE PACEMAKER, PERM & TEMP	Vitatron Medical BV	1984-09-24	237
K831860	GENERATOR, PULSE, PACEMAKER #532	Vitatron Medical BV	1983-10-27	139
K831859	PACEMAKER PROGRAMMER #2032	Vitatron Medical BV	1983-10-27	139
K810928	ENDOCARDIAL ELECTRODE	Vitatron Medical BV	1981-07-02	87
K791920	CARDIAC PACEMAKER P4000 SER. & P1000	Vitatron Medical BV	1979-11-29	65
K791921	CARDIAC PACEMAKER C4000, C1000 SER.	Vitatron Medical BV	1979-10-26	31
K791380	VA 1000	Vitatron Medical BV	1979-09-19	57
K790666	VITALITH S 3000 SERIES	Vitatron Medical BV	1979-06-01	56
K781168	GENERATOR, PULSE, PACEMAKER	Vitatron Medical BV	1978-08-31	49
K780717	EXTERNAL TEST PULSE GENERATOR	Vitatron Medical BV	1978-06-30	64
K772009	CARDIAC PACEMAKER S6001	Vitatron Medical BV	1977-11-28	34
K772010	CARDIAC PACEMAKER C2001	Vitatron Medical BV	1977-11-28	34
K760669	PACEMAKERS, VITATRON'S	Vitatron Medical BV	1976-11-12	56
K760671	PACEMAKERS, VITATRONS (SERIES 3000)	Vitatron Medical BV	1976-11-12	56
K760670	PACEMAKERS, VITATRONS (SERIES 2000)	Vitatron Medical BV	1976-11-12	56

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