510(k) · Cleared
ClearedIrrigation Channel Tubing, Model 100135
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Dec 23, 2003 as substantially equivalent to K031773 (Byrne Medical, Inc., 2003) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Dec 23, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011016 (2001). 5 ancestors in all, the oldest K884836 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011016 Lsi Solutions Flexible Suture Placement Device and Accessories ProductLsi Solutions · 2001 · Recalled
- 1 generation backK024301 Lsi Endoscopic External Accessory Channel and Accessories ProductLsi Solutions · 2003
- This deviceK033695 Irrigation Channel Tubing, Model 100135Byrne Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK092461 Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139…United States Endoscopy Group, Inc. · 2009 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K092461Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140United States Endoscopy Group, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories Product | Lsi Solutions | 2001 | 1 |
| −1 | K024301 | Lsi Endoscopic External Accessory Channel and Accessories Product | Lsi Solutions | 2003 | — |
| 0 (this device) | K033695 | Irrigation Channel Tubing, Model 100135 | Byrne Medical, Inc. | 2003 | — |
| +1 | K092461 | Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140 | United States Endoscopy Group, Inc. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031773 | Endo Gator SystemSummary page 4…scope and accessories Classification Name: | Accessofies, Cleaning, for Endoscope 3. Predicate Devices: Device Name Manufacturer K™ # Endo Gator™ System Byrne Medical K031773 Lsi Endoscope External | Lsi Solutions K024301 Accessory 4. Classification and Product Code: 21 CFR § 876.1500, Class Il, 78 KOG… | 2003 |
| * | K024301 | Lsi Endoscopic External Accessory Channel and Accessories ProductSummary page 4…ccessofies, Cleaning, for Endoscope 3. Predicate Devices: Device Name Manufacturer K™ # Endo Gator™ System Byrne Medical K031773 Lsi Endoscope External | Lsi Solutions K024301 Accessory 4. Classification and Product Code: 21 CFR § 876.1500, Class Il, 78 KOG. 5. Description: 100135 — Byrne Medical Irri… | 2003 |
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 |
|---|---|---|---|
| K092461 | Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140 | 2009 | 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 2 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K092461 (United States Endoscopy Group, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K031773.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Byrne Medical Irrigation Channel Tubing is used with the Byrne Medical Endo Gator System and connects to the output tubing from the pump and goes down the channel of an Endoscope. The Byrne Medical Irrigation Channel Tubing is provided sterile and is labeled for single use only.
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/K033695 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033695: Irrigation Channel Tubing, Model 100135.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033695
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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