Atlas FDA

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

Bio Protech, Inc. — Predicate Candidate Screening

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

82 daysmedian FDA review time
301 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.2019-08-29300
K152984Disposable Concentric Needle electrodes, Disposable MonopolaBio Protech, Inc.2016-06-032380
K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Bio Protech, Inc.2016-03-211580
K143103PROPENCIL Smoke PencilBio Protech, Inc.2015-07-162600
K142099CUTANEOUS ELECTRODESBio Protech, Inc.2014-11-171080
K111270REUSABLE STIMULATING ELECTRODESBio Protech, Inc.2011-09-131330
K100246MAX-IF1000Bio Protech, Inc.2010-11-243010
K091248MAXEMS, MODELS 1000 AND 2000Bio Protech, Inc.2009-11-302160
K092732PROPENCIL ESU PENCILBio Protech, Inc.2009-11-25820
K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F Bio Protech, Inc.2009-11-24760
K083148TELECTRODE WET GEL ECG ELECTRODEBio Protech, Inc.2008-11-07140
K073438PROSTIM 1000/2000Bio Protech, Inc.2008-02-07620
K073360PROPLATEBio Protech, Inc.2007-12-19190
K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20Bio Protech, Inc.2005-12-14490
K042301PROTENS ELECTRODEBio Protech, Inc.2004-09-0390
K040784PROTAB ECG TABB ELECTRODEBio Protech, Inc.2004-04-0790
K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILEBio Protech, Inc.2002-11-073090

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