# Bio Protech, Inc.

- Location (FDA's records): Crofton, MD
- FDA decisions: 17 (2002–2019): 17 510(k) clearances
- Product codes: DRX (4), GXY (4), GEI (4), FYD (1), GZJ (1), IKT (1), LIH (1), IPF (1)
- Predicates its devices cite: 18 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Leonhard Lang GmbH: 4 (https://510kreport.com/company/leonhard-lang)
- Conmedcorp: 2 (https://510kreport.com/company/conmedcorp)
- Biomedical Life Systems, Inc.: 1 (https://510kreport.com/company/biomedical-life-systems)
- Theratech, Inc.: 1 (https://510kreport.com/company/theratech)
- Johari Digital Healthcare, Ltd.: 1 (https://510kreport.com/company/johari-digital-healthcare)
- Bionen S.A.S.: 1 (https://510kreport.com/company/bionen)
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)
- Axon Systems, Inc.: 1 (https://510kreport.com/company/axon-systems)

## Firms that cite its devices most
- Cardiac Lead Technologies, Inc.: 2 (https://510kreport.com/company/cardiac-lead-technologies)
- Medico Electrodes International, Ltd.: 2 (https://510kreport.com/company/medico-electrodes-international)
- Safer Surgeries Medical Devices, LLC: 1 (https://510kreport.com/company/safer-surgeries-medical-devices)
- Leonhard Lang GmbH: 1 (https://510kreport.com/company/leonhard-lang)

## Its most-cited devices
- K020003: Electrocardiograph (Ecg) Electrode, Non-Sterile (2002), cited by 2
- K040784: Protab Ecg Tabb Electrode (2004), cited by 1
- K111270: Reusable Stimulating Electrodes (2011), cited by 1
- K142099: Cutaneous Electrodes (2014), cited by 1
- K053011: Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20 (2005), cited by 1
- K092732: Propencil Esu Pencil (2009), cited by 1

## Recent decisions
- K192035: EvaQMax Smoke Evacuation System (Aug 29, 2019)
- K152984: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (Jun 3, 2016)
- K153019: Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (Mar 21, 2016)
- K143103: PROPENCIL Smoke Pencil (Jul 16, 2015)
- K142099: Cutaneous Electrodes (Nov 17, 2014)
- K111270: Reusable Stimulating Electrodes (Sep 13, 2011)
- K100246: MAX-IF1000 (Nov 24, 2010)
- K091248: Maxems, Models 1000 and 2000 (Nov 30, 2009)

Source page: https://510kreport.com/company/bio-protech