# Byrne Medical, Inc.

- Location (FDA's records): Conroe, TX
- FDA decisions: 13 (2003–2012): 13 510(k) clearances
- Names in FDA's records: Byrne Medical, Inc. (12); Byrne Medical Incorporated (1)
- Product codes: OCX (5), ODC (4), FCX (1), FAJ (1), FEQ (1), FBK (1)
- Predicates its devices cite: 20 (7 its own); citations of its devices by later devices: 69 (7 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Endo Smart Cap Co.: 2 (https://510kreport.com/company/endo-smart-cap)
- Olympus Optical Co., Ltd.: 2 (https://510kreport.com/company/olympus-optical)
- United States Endoscopy Group, Inc.: 2 (https://510kreport.com/company/united-states-endoscopy-group)
- Celon AG Medical Instruments: 1 (https://510kreport.com/company/celon-ag-medical-instruments)
- E-Z-Em, Inc.: 1 (https://510kreport.com/company/e-z-em)
- Olympus Corp.: 1 (https://510kreport.com/company/olympus)
- Lsi Solutions: 1 (https://510kreport.com/company/lsi-solutions)
- Xylog Corp.: 1 (https://510kreport.com/company/xylog)

## Firms that cite its devices most
- Medivators (A Subsidiary of Steris Corporation): 9 (https://510kreport.com/company/medivators-a-subsidiary-of-steris)
- Ga Health Company Limited: 6 (https://510kreport.com/company/ga-health)
- Smartdata Suzhou Co., Ltd.: 4 (https://510kreport.com/company/smartdata-suzhou)
- Erbe USA, Inc.: 4 (https://510kreport.com/company/erbe-usa)
- Wilson Instruments (Sha) Co., Ltd.: 4 (https://510kreport.com/company/wilson-instruments-sha)
- Medivators, Inc.: 4 (https://510kreport.com/company/medivators)
- Endochoice, Inc.: 3 (https://510kreport.com/company/endochoice)
- Anrei Medical (Hangzhou) Co., Ltd.: 3 (https://510kreport.com/company/anrei-medical-hangzhou)

## Its most-cited devices
- K092429: Endogator (2009), cited by 13
- K093665: Endo Smartcap (2009), cited by 9
- K102409: Defendo Disposable Air/Water Valve Model 100304 (2010), cited by 9
- K102581: Defendo Disposable Suction Valve Model 100305 (2010), cited by 9
- K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R) (2009), cited by 9
- K102855: Universal Irrigation Solution Hybrid (2010), cited by 5

## Recent decisions
- K113310: Endogater Avantage CO2 Insufflator (Jun 20, 2012)
- K113119: Endogator Advantage Irrigation Pump (Apr 27, 2012)
- K110088: Defendo Y-Opsy Irrigator (Jun 10, 2011)
- K102855: Universal Irrigation Solution Hybrid (Nov 19, 2010)
- K102581: Defendo Disposable Suction Valve Model 100305 (Nov 8, 2010)
- K102409: Defendo Disposable Air/Water Valve Model 100304 (Nov 4, 2010)
- K093665: Endo Smartcap (Dec 15, 2009)
- K092090: Erbelift Hand Pump and Flexible Probe (Nov 30, 2009)

Source page: https://510kreport.com/company/byrne-medical