510(k) · Cleared
ClearedEndo Gator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Jun 24, 2003 as substantially equivalent to K971125 (Endo Smart Cap Co., 1997) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1988. 58 later devices descend from it.
- Decided
- Jun 24, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884836 (1988). 2 ancestors in all. 58 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- This deviceK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- Descendant · cites it directly · 41 of its ownK092429 EndogatorByrne Medical, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK091305 ClearpathEasyglide, Ltd. · 2009
- Descendant · 2 generations on · 10 of its ownK093779 Clearpath UgiEasyglide, Ltd. · 2010
- Descendant · 2 generations on · 8 of its ownK113050 Clearpath Lower GIEasyglide, Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK220395 EndoGator Endoscopy Irrigation TubingSTERIS Corporation · 2022
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K092429EndogatorByrne Medical, Inc. · 2009 · cites it directly41descendants
- K091305ClearpathEasyglide, Ltd. · 2009 · cites it directly13descendants
- K093779Clearpath UgiEasyglide, Ltd. · 2010 · 2 generations on10descendants
- K113050Clearpath Lower GIEasyglide, Ltd. · 2012 · 2 generations on8descendants
- K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| 0 (this device) | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| +1 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| +1 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| +2 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
| +2 | K113050 | Clearpath Lower GI | Easyglide, Ltd. | 2012 | — |
| +2 | K220395 | EndoGator Endoscopy Irrigation Tubing | STERIS Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 6 | 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 OCX? 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 OCX device
- #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K971125 | Endo Smartcap (100501)Summary page 4…em Common Name: Water Bottle Adapter Classification Name: | Endoscopes and Accessories 3. Predicate Devices: Device Name Manufacturer K # Endo SmartCap™ Byme Medical K971125* UGI-3000B Meditron K884836 * Note: Company name changed from Endo Smart Cap Co to Byme Medical. 4. Classification and Product… | 1997 |
| * | K884836 | Universal Generator Irrigator Model Ugi-3000Summary page 4…e Adapter Classification Name: | Endoscopes and Accessories 3. Predicate Devices: Device Name Manufacturer K # Endo SmartCap™ Byme Medical K971125* UGI-3000B Meditron K884836 * Note: Company name changed from Endo Smart Cap Co to Byme Medical. 4. Classification and Product Code: 21 CFR § 876.1500, Cla… | 1988 |
What descends from it? (58)
See all 585 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 2025
MAUDE reports naming product code OCX, 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 | 0 |
| 2010 | 3 | 51 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 256 | 0 | 1 |
| 2013 | 3 | 106 | 0 | 1 |
| 2014 | 6 | 77 | 0 | 5 |
| 2015 | 2 | — | 1 | 9 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 5 | 60 | 0 | 18 |
| 2019 | 8 | 133 | 0 | 41 |
| 2020 | 4 | 88 | 11 | 11 |
| 2021 | 3 | 233 | 0 | 8 |
| 2022 | 6 | 84 | 2 | 18 |
| 2023 | 7 | 109 | 0 | 46 |
| 2024 | 4 | 74 | 0 | 21 |
| 2025 | 4 | 178 | 0 | 33 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units.
The Endo Gator Cartridge is inlended as a replacement cartridge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap.
The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031773 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031773: Endo Gator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031773
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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