510(k) · Cleared
ClearedClearjet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Easyglide, Ltd. · ODC Endoscope Channel Accessory
Cleared on May 17, 2010 as substantially equivalent to K091305 (Easyglide, Ltd., 2009) and 1 other predicate after a 27-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- May 17, 2010
- Review
- 27 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921244 (1992). 27 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 deviceK101094 ClearjetEasyglide, Ltd. · 2010
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) | K101094 | Clearjet | Easyglide, Ltd. | 2010 | — |
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 |
| 2007 | 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 ODC? 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 ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 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 |
|---|---|---|---|
| * | K091305 | ClearpathSummary page 1…KOG - endoscope and/or accessories CFR 876.1500 Device: ClearJet Predicate Devices: K09 1305 - Easy Glide - ClearPath K0070420 - US Endoscope BioShield Device Description: The proposed C… | 2009 |
| * | K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138Summary page 2…e predicate device, ClearPath K09 1305 or have been tested per ISO 10993. Environment of Use - *Identical to predicates - K09 1305 - EasyGlide ClearPath and K070420 - US Endoscopy Rio-Shield Pa… | 2007 |
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 18 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 27 ancestors have a recall of any class.
- 3 other devices also cite its predicate K091305.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The ClearJet is an irrigation /biopsy adapter set used to cover the opening to the biopsy/ suction / irrigation channel of Pentax, Olympus and Fuijinon endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access, for irrigation.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101094: Clearjet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101094
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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