510(k) Report

FDA applicant

Byrne Medical, Inc.

Conroe, TX13 decisions2003–20127 recalls

FDA records 13 decisions for Byrne Medical, Inc. (Conroe, TX) from 2003 to 2012: 13 510(k) clearances. Most are in product codes OCX (Endoscopic Irrigation/Suction System) and ODC (Endoscope Channel Accessory). Its devices cite 20 predicates, 7 of them its own earlier devices. 7 recalls are linked to its devices.

FDA’s records also spell it “Byrne Medical Incorporated”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Byrne Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2009: 42010: 32011: 12012: 2
2007high 4 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2019

2019: 7
2007high 7 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Byrne Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Byrne Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OCXEndoscopic Irrigation/Suction System5decisions
  • ODCEndoscope Channel Accessory4decisions
  • FCXInsufflator, Automatic Carbon-Dioxide For Endoscope1decision
  • FAJCystoscope And Accessories, Flexible/Rigid1decision
  • FEQPump, Air, Non-Manual, For Endoscope1decision
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision

Whose devices does it build on?

Its devices cite 20 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 69 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092429EndogatorByrne Medical, Inc. · 200913cite it
  • K093665Endo SmartcapByrne Medical, Inc. · 20099cite it
  • K102409Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc. · 20109cite it
  • K102581Defendo Disposable Suction Valve Model 100305Byrne Medical, Inc. · 20109cite it
  • K090851Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy…Byrne Medical, Inc. · 20099cite it
  • K102855Universal Irrigation Solution HybridByrne Medical, Inc. · 20105cite it

What has FDA decided for it lately?

  • K113310Endogater Avantage CO2 InsufflatorByrne Medical, Inc. · 2012
  • K113119Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012
  • K110088Defendo Y-Opsy IrrigatorByrne Medical Incorporated · 2011
  • K102855Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
  • K102581Defendo Disposable Suction Valve Model 100305Byrne Medical, Inc. · 2010
  • K102409Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc. · 2010
  • K093665Endo SmartcapByrne Medical, Inc. · 20097 recalls
  • K092090Erbelift Hand Pump and Flexible ProbeByrne Medical, Inc. · 2009

All 12 as Byrne Medical, Inc. →The one decision as Byrne Medical Incorporated →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K093665Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Oct 9, 2019Class II
  • K093665Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50…Oct 9, 2019Class II
  • K093665Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Oct 9, 2019Class II
  • K093665Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50…Oct 9, 2019Class II
  • K093665Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended…Oct 9, 2019Class II
  • K093665Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10…Oct 9, 2019Class II