Atlas FDA

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

Siemens-Pacesetter, Inc. — Predicate Candidate Screening

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

333 daysmedian FDA review time
648 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942440AFP CARDIAC PACING SYSTEM MODEL 283Siemens-Pacesetter, Inc.1994-08-08800
K925038PACING LEAD MODEL 1188TSiemens-Pacesetter, Inc.1994-07-156480
K932892PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELSSiemens-Pacesetter, Inc.1994-07-063870
K930876SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146TSiemens-Pacesetter, Inc.1994-06-154810
K925347MODEL 1148T TRANSVENOUS, SCREW-IN LEADSiemens-Pacesetter, Inc.1993-06-102310
K920822CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODESiemens-Pacesetter, Inc.1993-01-223330
K921318ADAPTING SLEEVE KIT MODEL 4023Siemens-Pacesetter, Inc.1992-08-031370

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