# K092429: Endogator

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Nov 19, 2009 after 104 days
- Product code: FEQ (Pump, Air, Non-Manual, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884836 (1988). 4 ancestors in all.
41 later devices descend from it; 13 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031773: Endo Gator System, Byrne Medical, Inc. (2003) Summary page 1.
- K000948: Olympus Endoscopic Flushing Pump Model Ofp-1, Keymed (Medical & Industrial Equipment), Ltd. (2000) Summary page 1.

## Most influential descendants
- K220395: EndoGator Endoscopy Irrigation Tubing (2022), 7 descendants of its own
- K200769: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (2021), 7 descendants of its own
- K102855: Universal Irrigation Solution Hybrid (2010), 7 descendants of its own
- K232329: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter (2023), 3 descendants of its own
- K220210: Disposable Endoscopy Adapter Set (2022), 3 descendants of its own

## Indications for use
The EndoGator TM system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

Source page: https://510kreport.com/device/K092429
Methodology: https://510kreport.com/methodology