Atlas FDA

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

Tpl-Cordis, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
150 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K885240MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEADTpl-Cordis, Inc.1989-02-10510
K882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.1988-07-22380
K880898MULTICOR AND PACEMAKERSTpl-Cordis, Inc.1988-05-06700
K880432VICOR PACER, MODEL 410ATpl-Cordis, Inc.1988-02-22250
K873158MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERSTpl-Cordis, Inc.1988-01-071500
K873202VICOR, MODEL 410ATpl-Cordis, Inc.1987-10-15630

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