510(k) · Cleared
ClearedAndorate Biopsy Valve, Andorate Biopsy Irrigator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ga Health Company Limited · ODC Endoscope Channel Accessory
Cleared on Jun 18, 2020 as substantially equivalent to K090851 (Byrne Medical, Inc., 2009) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Jun 18, 2020
- Review
- 112 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K884836 (1988). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 3 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 2 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 1 generation backK110088 Defendo Y-Opsy IrrigatorByrne Medical Incorporated · 2011
- This deviceK200481 Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited · 2020
- Descendant · cites it directly · 0 of its ownK230932 ANDORATE® Valve KitGa Health Company Limited · 2023
Most influential descendants
Showing 1 of 1 · See all- K230932ANDORATE® Valve KitGa Health Company Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −3 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −2 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −1 | K110088 | Defendo Y-Opsy Irrigator | Byrne Medical Incorporated | 2011 | — |
| 0 (this device) | K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | Ga Health Company Limited | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K090851 | Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301…Summary page 4…Regulation Number: &)5876.1500 Regulatory Class: 2 5. Predicate Device Identification Predicate Device 510(k) No.: K090851 Predicate Device Trade Name: DEFENDOTM Disposable Biopsy Valve Predicate Device Product Code: ODC Pre… | 2009 |
| * | K110088 | Defendo Y-Opsy IrrigatorSummary page 4…0851 Predicate Device Trade Name: DEFENDOTM Disposable Biopsy Valve Predicate Device Product Code: ODC Predicate Device 510(k) No.: K110088 Predicate Device Trade Name: DEFENDOTM Y-Opsy Irrigator Predicate Device Product Code: ODC… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230932 | ANDORATE® Valve Kit | 2023 | 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 32 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K230932 (Ga Health Company Limited, 2023) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K090851.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial firom the biopsy port throughout the endoscopic procedure.
The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope’s biopsy channel.
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/K200481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200481: Andorate Biopsy Valve, Andorate Biopsy Irrigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200481
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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