510(k) · Cleared
ClearedEndogator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical, Inc. · FEQ Pump, Air, Non-Manual, For Endoscope
Cleared on Nov 19, 2009 as substantially equivalent to K031773 (Byrne Medical, Inc., 2003) and 1 other predicate after a 104-day review. Its family tree reaches back 2 generations to 1988. 41 later devices descend from it.
- Decided
- Nov 19, 2009
- Review
- 104 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884836 (1988). 4 ancestors in all. 41 later devices descend from it, 13 citing it directly.
- Root · 2 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 1 generation backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- This deviceK092429 EndogatorByrne Medical, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK220395 EndoGator Endoscopy Irrigation TubingSTERIS Corporation · 2022
- Descendant · cites it directly · 7 of its ownK200769 Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021
- Descendant · cites it directly · 7 of its ownK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700…Medivators (A Subsidiary of Steris Corporation) · 2023
- Descendant · 2 generations on · 3 of its ownK220210 Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation · 2022 · cites it directly7descendants
- K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021 · cites it directly7descendants
- K102855Universal Irrigation Solution HybridByrne Medical, Inc. · 2010 · cites it directly7descendants
- K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation) · 2023 · 2 generations on3descendants
- K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −1 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| 0 (this device) | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| +1 | K220395 | EndoGator Endoscopy Irrigation Tubing | STERIS Corporation | 2022 | — |
| +1 | K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B | Wilson Instruments (Sha) Co., Ltd. | 2021 | — |
| +1 | K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | 2010 | — |
| +2 | K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use… | Medivators (A Subsidiary of Steris Corporation) | 2023 | — |
| +2 | K220210 | Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FEQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FEQ device
- #1 K220395 EndoGator Endoscopy Irrigation Tubingscore 15.6 · 3 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031773 | Endo Gator SystemSummary page 1…(s): Device Name Manufacturer "K"No EndoGatorTm Byrne Medical, Inc. K031773 Endoscopic Flushing Pump Olympuse K000948 Model OFP-1 4. Classificatio… | 2003 |
| * | K000948 | Olympus Endoscopic Flushing Pump Model Ofp-1Summary page 1…"K"No EndoGatorTm Byrne Medical, Inc. K031773 Endoscopic Flushing Pump Olympuse K000948 Model OFP-1 4. Classification and Product Code: 21 CFR § 876.1500, Class II,78 KOG. 5. Descriptio… | 2000 |
What descends from it? (41)
See all 4113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220395 | EndoGator Endoscopy Irrigation Tubing | 2022 | 7 |
| K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B | 2021 | 7 |
| K102855 | Universal Irrigation Solution Hybrid | 2010 | 7 |
| K120862 | Water Bottle Cap Irrigaton System | 2012 | 3 |
| K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes | 2011 | 3 |
| K202560 | AquaPulse Irrigation Tubing | 2020 | 2 |
| K110088 | Defendo Y-Opsy Irrigator | 2011 | 2 |
| K203350 | ENDOtube | 2021 | 1 |
| K200479 | AquaPulse Auxiliary Water Connector | 2020 | 1 |
| K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K220395 (STERIS Corporation, 2022) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K031773.
How does its category compare?
All FEQ devicesFEQ Pump, Air, Non-Manual, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FEQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FEQ
29in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEQ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEQ
341in 2025
MAUDE reports naming product code FEQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 84 | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 1 | 4 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 1 |
| 2016 | 3 | 29 | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 22 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 1 | 705 |
| 2025 | 0 | — | 0 | 341 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092429: Endogator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092429
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026