510(k) · Cleared
ClearedDefendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
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 Dec 21, 2023 as substantially equivalent to K102409 (Byrne Medical, Inc., 2010) and 4 other predicates after a 140-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 21, 2023
- Review
- 140 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K944759 (1995). 21 ancestors in all, the oldest K884836 (1988). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 5 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- 4 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- 3 generations backK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
- 2 generations backK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
- 1 generation backK172916 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and…Fujifilm Corporation · 2018
- This deviceK232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700…Medivators (A Subsidiary of Steris Corporation) · 2023
- Descendant · cites it directly · 1 of its ownK240352 Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024
- Descendant · cites it directly · 0 of its ownK250140 Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025
- Descendant · 2 generations on · 0 of its ownK243075 Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322…STERIS Corporation · 2024
Most influential descendants
Showing 3 of 3 · See all- K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024 · cites it directly1descendant
- K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025 · cites it directly0descendants
- K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…STERIS Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −5 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| −4 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| −3 | K132210 | Fujifilm 600 Series Endoscopes | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −2 | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| −1 | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and… | Fujifilm Corporation | 2018 | — |
| 0 (this device) | K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use… | Medivators (A Subsidiary of Steris Corporation) | 2023 | — |
| +1 | K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | 2024 | — |
| +1 | K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | 2025 | — |
| +2 | K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323… | STERIS Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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 K220210 Disposable Endoscopy Adapter Setscore 13.4 · 4 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…tion Number: 21 CFR 876.1500 Product Code: ODC, FDF, OCX, and FEQ 2. Predicate Device(s) Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K210342 - B… | 2010 |
| * | K102581 | Defendo Disposable Suction Valve Model 100305Summary page 6…ODC, FDF, OCX, and FEQ 2. Predicate Device(s) Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K210342 - BioShield- Biopsy Valve K220395 - Endogator Endoscopy Irrig… | 2010 |
| * | K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield…Summary page 6…Primary predicate is listed first: K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K210342 - BioShield- Biopsy Valve K220395 - Endogator Endoscopy Irrigation Tubing K172916 - FUJIFILM Endoscope Models EG-760R… | 2021 |
| * | K220395 | EndoGator Endoscopy Irrigation TubingSummary page 6…K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K210342 - BioShield- Biopsy Valve K220395 - Endogator Endoscopy Irrigation Tubing K172916 - FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L an… | 2022 |
| * | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Summary page 6…100304 K102581 - Defendo Disposable Suction Valve Model 100305 K210342 - BioShield- Biopsy Valve K220395 - Endogator Endoscopy Irrigation Tubing K172916 - FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603… | 2018 |
What descends from it? (3)
2 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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K240352 (STERIS Corporation, 2024) has gone furthest, with 1 descendant of its own.
- 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. 2023, 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 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, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.…
Read the full statement (154 words)
The 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, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The 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 Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The Single Use ENDOGATOR™ 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).
The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232329: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232329
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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