510(k) · Cleared
ClearedUniversal Irrigation Solution Hybrid
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 Nov 19, 2010 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) and 1 other predicate after a 51-day review. Its family tree reaches back 3 generations to 1988. 7 later devices descend from it.
- Decided
- Nov 19, 2010
- Review
- 51 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K884836 (1988). 7 ancestors in all, the oldest K790071 (1979). 7 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 2 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 1 generation backK092429 EndogatorByrne Medical, Inc. · 2009
- This deviceK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK132340 Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo…Erbe USA, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK162152 Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK231418 ENDOGATOR™ Hybrid Irrigation TubingMedivators · 2023
- Descendant · cites it directly · 0 of its ownK231602 Protego Air Water Connector; Protego Air Water Bottle Tubing…Ga Health Company Limited · 2023
- Descendant · cites it directly · 0 of its ownK220785 Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc. · 2013 · cites it directly2descendants
- K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · 2 generations on1descendant
- K231418ENDOGATOR™ Hybrid Irrigation TubingMedivators · 2023 · cites it directly0descendants
- K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingGa Health Company Limited · 2023 · cites it directly0descendants
- K220785Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −2 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −1 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| 0 (this device) | K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | 2010 | — |
| +1 | K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap… | Erbe USA, Inc. | 2013 | 1 |
| +2 | K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016 | 1 |
| +1 | K231418 | ENDOGATOR™ Hybrid Irrigation Tubing | Medivators | 2023 | — |
| +1 | K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid… | Ga Health Company Limited | 2023 | — |
| +1 | K220785 | Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K092429 | EndogatorSummary page 1…res and principles of operation between the Universal Irrigation Solution Hybrid7Tm and Predicate Devices, Byrne Medical Endooator®System and Byrne Medical SmartCap® ( K092429 and K093665 respectively). Characteristic… | 2009 |
| * | K093665 | Endo SmartcapSummary page 1…ciples of operation between the Universal Irrigation Solution Hybrid7Tm and Predicate Devices, Byrne Medical Endooator®System and Byrne Medical SmartCap® ( K092429 and K093665 respectively). Characteristic… | 2009 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2… | 2013 | 2 |
| K231418 | ENDOGATOR™ Hybrid Irrigation Tubing | 2023 | 0 |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | 2023 | 0 |
| K220785 | Clean Connecting Tube | 2022 | 0 |
| K193250 | Irrigation Tubing with CO2 or Air | 2020 | 0 |
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 22 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K132340 (Erbe USA, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K092429.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Universal Irrigation Solution HybridTM (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or 002 (via aCO2 pump) along with sterile water 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/K102855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102855: Universal Irrigation Solution Hybrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102855
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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