510(k) · Cleared
ClearedEndoStream (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Partnership Medical Limited · OCX Endoscopic Irrigation/Suction System
Cleared on Jul 11, 2019 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) and 1 other predicate after a 402-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Jul 11, 2019
- Review
- 402 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K884836 (1988). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 5 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 4 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 3 generations backK120862 Water Bottle Cap Irrigaton SystemEndochoice, Inc. · 2012
- 2 generations backK133747 Endochoice Water Bottle Cap Irrigation SystemEndochoice, Inc. · 2014
- 1 generation backK161482 EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc. · 2016
- This deviceK181457 EndoStream (TM)Partnership Medical Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −5 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −4 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −3 | K120862 | Water Bottle Cap Irrigaton System | Endochoice, Inc. | 2012 | — |
| −2 | K133747 | Endochoice Water Bottle Cap Irrigation System | Endochoice, Inc. | 2014 | — |
| −1 | K161482 | EndoChoice Water Bottle Cap Irrigation System | Endochoice, Inc. | 2016 | — |
| 0 (this device) | K181457 | EndoStream (TM) | Partnership Medical Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 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 7…doStream™ Company Predicate Device Name FDA 510(k) Number Byrne Medical, Inc. EndoGator K092429 EndoChoice, Inc. EndoChoice Water Bottle Cap K16482 Irrigation S… | 2009 |
| * | K161482 | EndoChoice Water Bottle Cap Irrigation SystemSummary page 8…ly equivalent to the Byrne Medical, Inc. (EndoGator, K092429), and the EndoChoice, Inc. (EndoChoice Water Bottle Cap Irrigation System, K161482) Characteristic Our Device Predicate 1 Predicate 2 Compared… | 2016 |
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 31 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 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. 2019, 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 EndoStream™ tubing is intended to provide irrigation via sterile water supply during gastrointestinal (GI) endoscopic procedures when used in conjunction with an irrigation pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181457: EndoStream (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181457
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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