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

Bio-Detek, Inc. — Predicate Candidate Screening

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

93 daysmedian FDA review time
260 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-paBio-Detek, Inc.2015-05-02930
K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.2015-05-021100
K133441ONESTEP CPR II MULTI-FUNCTION ELECTRODEBio-Detek, Inc.2014-10-103320
K100565DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYBio-Detek, Inc.2010-11-162600
K071321POCKETCPRBio-Detek, Inc.2007-09-121250
K040056BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90Bio-Detek, Inc.2004-04-09870
K040256PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MBio-Detek, Inc.2004-04-09650
K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNEBio-Detek, Inc.2004-02-27861
K984582ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XBio-Detek, Inc.1999-03-16830
K990106ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODESBio-Detek, Inc.1999-02-26450
K981802ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER Bio-Detek, Inc.1998-11-251880
K964213TRACE RITE SOLID GEL ECG ELECTRODESBio-Detek, Inc.1996-11-25340
K920352BIO-DETEK EEG ELECTRODEBio-Detek, Inc.1992-08-142000
K920264BIO-DETEK TRACERITE EEG ELECTRODEBio-Detek, Inc.1992-06-021330
K912714RT40 RADIO TRANSLUCENTBio-Detek, Inc.1991-07-25370
K853038DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODESBio-Detek, Inc.1986-01-071720
K853291GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300Bio-Detek, Inc.1985-10-10660

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