510(k) · Cleared
ClearedDefendo Y-Opsy Irrigator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical Incorporated · ODC Endoscope Channel Accessory
Cleared on Jun 10, 2011 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) and 1 other predicate after a 149-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Jun 10, 2011
- Review
- 149 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K884836 (1988). 6 ancestors in all. 2 later devices descend from it, 1 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 deviceK110088 Defendo Y-Opsy IrrigatorByrne Medical Incorporated · 2011
- Descendant · cites it directly · 1 of its ownK200481 Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited · 2020
- Descendant · 2 generations on · 0 of its ownK230932 ANDORATE® Valve KitGa Health Company Limited · 2023
Most influential descendants
Showing 2 of 2 · See allView 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) | K110088 | Defendo Y-Opsy Irrigator | Byrne Medical Incorporated | 2011 | — |
| +1 | K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | Ga Health Company Limited | 2020 | — |
| +2 | K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 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 ODC? 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 ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 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…and the Byrne Medical DEFEND O Tm Biopsy Valve. The Byrne Medical, Inc., DEFENDOTM Y-Opsy Irrigator and predicate device's (Byrne Medical Endogator@ System Y-Connector, K092429 and Byrne Medical DEFENDO Tm Biopsy Valve, K090851) are in Class 11,21 CFR 876.1500. The predicate devices' are manufactured by… | 2009 |
| * | K090851 | Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301…Summary page 1…e Byrne Medical, Inc., DEFENDOTM Y-Opsy Irrigator and predicate device's (Byrne Medical Endogator@ System Y-Connector, K092429 and Byrne Medical DEFENDO Tm Biopsy Valve, K090851) are in Class 11,21 CFR 876.1500. The predicate devices' are manufactured by Byrne Medical Inc., Conroe, Texas. The Byrne Medica… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | 2020 | 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 23 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K200481 (Ga Health Company Limited, 2020) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K092429.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The DEFENDOTM Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110088 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110088: Defendo Y-Opsy Irrigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110088
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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