510(k) · Cleared
ClearedIrrigation Tubing with CO2 or Air
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keymed (Medical and Industrial Equipment), Ltd. · OCX Endoscopic Irrigation/Suction System
Cleared on Apr 6, 2020 as substantially equivalent to K102855 (Byrne Medical, Inc., 2010) after a 133-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Apr 6, 2020
- Review
- 133 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K884836 (1988). 8 ancestors in all, the oldest K790071 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 3 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 2 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 1 generation backK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
- This deviceK193250 Irrigation Tubing with CO2 or AirKeymed (Medical and Industrial Equipment), Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −3 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −2 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −1 | K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | 2010 | — |
| 0 (this device) | K193250 | Irrigation Tubing with CO2 or Air | Keymed (Medical and Industrial Equipment), Ltd. | 2020 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K102855 | Universal Irrigation Solution HybridSummary page 4…Tubing with CO2 ƒ MAJ-2209 Irrigation Tubing with Air ƒ MAJ-2210 Irrigation Tubing with Air are considered substantially equivalent to legally marketed device of K102855, 21 CFR 876.1500: ƒ (100605) Universal Irrigation Solution Hybrid, Byrne Medical No reference devices were used in this submi… | 2010 |
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 32 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 4 other devices also cite its predicate K102855.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or air insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
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/K193250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193250: Irrigation Tubing with CO2 or Air.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193250
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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