510(k) · Cleared
ClearedScopeFlow Pure (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 K140753 (Medivators, 2014) and 1 other predicate after a 406-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Jul 11, 2019
- Review
- 406 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K790071 (1979). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK790071 Endoscope and AccessoriesOlympus Corp. · 1979 · Recalled
- 2 generations backK093665 Endo SmartcapByrne Medical, Inc. · 2009 · Recalled
- 1 generation backK140753 Endo Smart Bottle, Rinse and Insufflation SystemMedivators · 2014
- This deviceK181418 ScopeFlow Pure (TM)Partnership Medical Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K790071 | Endoscope and Accessories | Olympus Corp. | 1979 | 6 |
| −2 | K093665 | Endo Smartcap | Byrne Medical, Inc. | 2009 | 7 |
| −1 | K140753 | Endo Smart Bottle, Rinse and Insufflation System | Medivators | 2014 | — |
| 0 (this device) | K181418 | ScopeFlow Pure (TM) | Partnership Medical Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K140753 | Endo Smart Bottle, Rinse and Insufflation SystemSummary page 8…w Pure™ Company Predicate Device Name FDA 510(k) Number Medivators EndoSmart Bottle, Rinse and K140753 Insufflation System [Model: 100145U / 100150U / 100160U / 100… | 2014 |
| * | K971125 | Endo Smartcap (100501)Summary page 8…100145CO2EXTU / 100150CO2EXTU / 100165CO2EXTU] Endo The Endo SmartCap [Model: 100145 / K971125 SmartCap 100150] Company Partnership Medical Limited… | 1997 |
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 40 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
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 ScopeFlow Pure™ is designed to be used in conjunction with a flexible endoscope to insufflate air/CO2 and supply sterile water during endoscopic procedures. The ScopeFlow Pure™ is compatible with the different sterile water bottles available. It is intended to be used for 24 hours and then disposed of.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181418: ScopeFlow Pure (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181418
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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