510(k) · Cleared
ClearedENDOtube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nissha Medical Technologies Sas · OCX Endoscopic Irrigation/Suction System
Cleared on Sep 29, 2021 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) and 1 other predicate after a 320-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Sep 29, 2021
- Review
- 320 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K884836 (1988). 7 ancestors in all, the oldest K790071 (1979). 1 later device descends 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 deviceK203350 ENDOtubeNissha Medical Technologies Sas · 2021
- Descendant · cites it directly · 0 of its ownK221310 Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd. · 2022 · cites it directly0descendants
View 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) | K203350 | ENDOtube | Nissha Medical Technologies Sas | 2021 | — |
| +1 | K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | Changzhou Endoclean Medical Device Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OCX? 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 OCX device
- #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 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 5…PREDICATE DEVICE In order to properly cover the entire product range of the application, two predicates have been selected. The primary predicate is ENDOGATOR™ (K092429). Device Name ENDOGATOR™ ENDO SMART CAP™ 510(k)… | 2009 |
| * | K093665 | Endo SmartcapSummary page 5…ENDOGATOR™ ENDO SMART CAP™ 510(k) Number K092429 K093665 Class II II… | 2009 |
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 |
|---|---|---|---|
| K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | 2022 | 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 33 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K221310 (Changzhou Endoclean Medical Device Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K092429.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 2025
MAUDE reports naming product code OCX, 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 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 51 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 256 | 0 | 1 |
| 2013 | 3 | 106 | 0 | 1 |
| 2014 | 6 | 77 | 0 | 5 |
| 2015 | 2 | — | 1 | 9 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 5 | 60 | 0 | 18 |
| 2019 | 8 | 133 | 0 | 41 |
| 2020 | 4 | 88 | 11 | 11 |
| 2021 | 3 | 233 | 0 | 8 |
| 2022 | 6 | 84 | 2 | 18 |
| 2023 | 7 | 109 | 0 | 46 |
| 2024 | 4 | 74 | 0 | 21 |
| 2025 | 4 | 178 | 0 | 33 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203350: ENDOtube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203350
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