510(k) · Cleared
ClearedJetprep Flushing Device OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jetprep, Ltd. · OCX Endoscopic Irrigation/Suction System
Cleared on Apr 4, 2012 as substantially equivalent to K030765 (Hobbs Medical, Inc., 2003) after a 335-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Apr 4, 2012
- Review
- 335 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030765 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK030765 Hobbs Mistifier Spray CatheterHobbs Medical, Inc. · 2003 · Recalled
- This deviceK111274 Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 /…Jetprep, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK122740 Jetprep Flushing Device OL-103037, Jetprep Flushing Device…Jetprep, Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122740Jetprep Flushing Device OL-103037, Jetprep Flushing Device OL-133037, Jetprep Flushing…Jetprep, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030765 | Hobbs Mistifier Spray Catheter | Hobbs Medical, Inc. | 2003 | 2 |
| 0 (this device) | K111274 | Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 / PE-105038 /… | Jetprep, Ltd. | 2012 | — |
| +1 | K122740 | Jetprep Flushing Device OL-103037, Jetprep Flushing Device OL-133037, Jetprep… | Jetprep, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K030765 | Hobbs Mistifier Spray CatheterSummary page 1…F.R. § 876.1500 Predicate Devices: Hobbs Mistifier Spray Catheter Hobbs Medical, Inc. K030765 Device Description: The JetPrep Flushing Device is a sterile, disposable, single… | 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 |
|---|---|---|---|
| K122740 | Jetprep Flushing Device OL-103037, Jetprep Flushing Device OL-133037, Jetprep Flushing… | 2012 | 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?
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 JetPrep Flushing Device is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111274: Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111274
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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