510(k) · Cleared
ClearedClearpath 24
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedic, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Jun 29, 2012 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) and 2 other predicates after a 323-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jun 29, 2012
- Review
- 323 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921244 (1992). 28 ancestors in all, the oldest K822846 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 2 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 1 generation backK091305 ClearpathEasyglide, Ltd. · 2009
- This deviceK112318 Clearpath 24Promedic, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −5 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −4 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −3 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −2 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −1 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| 0 (this device) | K112318 | Clearpath 24 | Promedic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (3)
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 1…Class - 2 CFR 876.1500 Device: ClearPath Tubing Predicate Devices: K092429 - Byrne Medical - Endogator K091305 - EasyGlide - ClearPath K… | 2009 |
| * | K091305 | ClearpathSummary page 1…CFR 876.1500 Device: ClearPath Tubing Predicate Devices: K092429 - Byrne Medical - Endogator K091305 - EasyGlide - ClearPath K 103239 -US Endoscopy -Velocity Irrigation system Device Description:… | 2009 |
| * | K103239 | Irrigation SystemSummary page 1…Predicate Devices: K092429 - Byrne Medical - Endogator K091305 - EasyGlide - ClearPath K 103239 -US Endoscopy -Velocity Irrigation system Device Description: The ClearPath Tubing is intended to provide irrigation via irrigat… | 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 20 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 28 ancestors have 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. 2012, 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 ClearPath Tubing is intended to provide irrigation via irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Lower G1, ClearPath Upper G1, and ClearPath Irrigator).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112318: Clearpath 24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112318
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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