Atlas FDA

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

Burdick, Inc. — Predicate Candidate Screening

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

275 daysmedian FDA review time
483 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952417QUEST EXERCISE STRESS SYSTEMBurdick, Inc.1996-05-223650
K954267BURDICK 200 PULSE OXIMETERBurdick, Inc.1996-05-032340
K946281ECLIPSE 4 ELECTROCARDIOGRAPHBurdick, Inc.1996-04-234830
K945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 840Burdick, Inc.1995-07-032070
K943959ECLIPSE 4 ELECTROCARDIOGRAPHBurdick, Inc.1995-05-172750
K942438ALTAIR 6100 CASSETTE RECORDERBurdick, Inc.1994-08-05770

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