510(k) · Cleared
ClearedDefendo Fujifilm 700 Single Use Cleaning Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris Corparation · ODC Endoscope Channel Accessory
Cleared on Feb 20, 2025 as substantially equivalent to K232329 (Medivators (A Subsidiary of Steris Corporation), 2023) after a 34-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Feb 20, 2025
- Review
- 34 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944759 (1995). 22 ancestors in all, the oldest K884836 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 6 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- 5 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- 4 generations backK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
- 3 generations backK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
- 2 generations backK172916 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and…Fujifilm Corporation · 2018
- 1 generation backK232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700…Medivators (A Subsidiary of Steris Corporation) · 2023
- This deviceK250140 Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −6 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| −5 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| −4 | K132210 | Fujifilm 600 Series Endoscopes | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −3 | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| −2 | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and… | Fujifilm Corporation | 2018 | — |
| −1 | K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use… | Medivators (A Subsidiary of Steris Corporation) | 2023 | — |
| 0 (this device) | K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | 2025 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Summary page 5…Regulation Number: 21 CFR 876.1500 Product Code: ODC 2. Predicate Device Defendo Fujifilm 700 Single Use Cleaning Adaptor, K232329 3. Device Description This device is intended to be used only to pre-clean the endoscope's air/water channel post-pr… | 2023 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K232329.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Fujifilm 700 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/K250140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250140: 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/K250140
Report an extraction error
Are you the manufacturer?
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