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

Edwards Pacemaker Systems — Predicate Candidate Screening

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

35 daysmedian FDA review time

59 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K791751	EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR	Edwards Pacemaker Systems	1979-09-26	21
K790452	28 UNIPOLAR AND BIPOLAR PULSE GENERATORS	Edwards Pacemaker Systems	1979-05-08	64
K781111	LEAD CONVERSION KIT, MODEL 341	Edwards Pacemaker Systems	1978-08-31	59
K781144	ANALYZER, PACER SYSTEM, PSA-5	Edwards Pacemaker Systems	1978-08-23	44
K781042	PROLITH 23S PACEMAKER	Edwards Pacemaker Systems	1978-07-27	37
K780780	MICROPULSE 22S PACEMAKER	Edwards Pacemaker Systems	1978-06-30	50
K780238	PACEMAKER, PROLITH 23U. PULSE GENERATOR	Edwards Pacemaker Systems	1978-03-15	30
K780091	MICROPULSE 22U	Edwards Pacemaker Systems	1978-01-30	14
K771987	MICROPULSE 26U PULSE GENERATOR	Edwards Pacemaker Systems	1977-11-02	14
K770656	GENERATOR, PULSE, CARDIAC 20U	Edwards Pacemaker Systems	1977-04-26	19
K770657	GENERATOR, PULSE, CARDIAC 2LU	Edwards Pacemaker Systems	1977-04-26	19
K770212	PROLITH MODEL 21S CARDIAC PULSE GEN.	Edwards Pacemaker Systems	1977-03-09	37
K770211	MICROPULSE MODEL 20S	Edwards Pacemaker Systems	1977-03-07	35

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