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

Siemens Burdick, Inc. — Predicate Candidate Screening

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

161 daysmedian FDA review time
318 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K915327ELITE II ELECTROCARDIOGRAPH,MODIFIEDSiemens Burdick, Inc.1992-10-093180
K915225MEGACARTSiemens Burdick, Inc.1992-07-012240
K915202INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPHSiemens Burdick, Inc.1992-05-151790
K914969E350I ELECTROCARDIOGRAPHSiemens Burdick, Inc.1992-03-261420
K913518TA620 TREADMILL CONTROLLERSiemens Burdick, Inc.1991-10-24780
K910634DC200 DEFIBRILLATORSiemens Burdick, Inc.1991-07-241610
K910867T600 TREADMILLSiemens Burdick, Inc.1991-05-31910

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