Atlas FDA

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

Pacesetter, Inc. — Predicate Candidate Screening

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

122 daysmedian FDA review time
297 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972814LOCATOR MODEL 4036Pacesetter, Inc.1998-02-232090
K960854SIEMENS SERVO ULTRA NEBULIZER 345Pacesetter, Inc.1996-12-232970
K954714AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)Pacesetter, Inc.1996-02-011220
K954551DF-1 TERMINAL CAPPacesetter, Inc.1995-12-26850
K951950PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATINGPacesetter, Inc.1995-08-311270
K952206PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATINGPacesetter, Inc.1995-08-311130
K951087TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEADPacesetter, Inc.1995-06-291120
K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069Pacesetter, Inc.1995-04-06830

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