510(k) · Cleared
ClearedDefendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivators (A Subsidiary of Steris Corporation) · ODC Endoscope Channel Accessory
Cleared on Mar 6, 2024 as substantially equivalent to K102409 (Byrne Medical, Inc., 2010) and 4 other predicates after a 244-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Mar 6, 2024
- Review
- 244 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K884836 (1988). 10 ancestors in all. No later device cites it as a predicate yet.
- 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 backK220395 EndoGator Endoscopy Irrigation TubingSTERIS Corporation · 2022
- This deviceK232004 Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use…Medivators (A Subsidiary of Steris Corporation) · 2024
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 | K220395 | EndoGator Endoscopy Irrigation Tubing | STERIS Corporation | 2022 | — |
| 0 (this device) | K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water… | Medivators (A Subsidiary of Steris Corporation) | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 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 14.1 · 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? (5)
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 |
|---|---|---|---|
| * | K102409 | Defendo Disposable Air/Water Valve Model 100304Summary page 6…Classification Number: 21 CFR 876.1500 Product Code: ODC 2. Predicate Device(s) Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - D… | 2010 |
| * | K102581 | Defendo Disposable Suction Valve Model 100305Summary page 6…ct Code: ODC 2. Predicate Device(s) Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - Defendo Biopsy Valves K220395 - Endogator Endoscopy Irrigat… | 2010 |
| * | K090851 | Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301…Summary page 6…Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - Defendo Biopsy Valves K220395 - Endogator Endoscopy Irrigation Tubing 3. Description of Device The Defendo Pent… | 2009 |
| * | K220395 | EndoGator Endoscopy Irrigation TubingSummary page 6…K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - Defendo Biopsy Valves K220395 - Endogator Endoscopy Irrigation Tubing 3. Description of Device The Defendo Pentax Single Use Valves Set, the subject… | 2022 |
| * | K092429 | EndogatorSummary page 10…le Use Connector Feature Comparison Connector (K092429) (Subject Device) The Endogator Intended Use Pentax Connector is… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 4 companies; a new generation was cleared every 12.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 8 other devices also cite its predicate K102409.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Defendo Pentax Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve…
Read the full statement (134 words)
The Defendo Pentax Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232004: Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232004
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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