510(k) · Cleared
Recalled · Class II · 2022Hobbs Mistifier Spray Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hobbs Medical, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Jun 9, 2003 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 9, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- OCX
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK030765 Hobbs Mistifier Spray CatheterHobbs Medical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK111274 Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 /…Jetprep, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK182319 Glo-Tip Spray CatheterWilson-Cook Medical, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK122740 Jetprep Flushing Device OL-103037, Jetprep Flushing Device…Jetprep, Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See all- K111274Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 /…Jetprep, Ltd. · 2012 · cites it directly1descendant
- K182319Glo-Tip Spray CatheterWilson-Cook Medical, Inc. · 2019 · cites it directly0descendants
- K122740Jetprep Flushing Device OL-103037, Jetprep Flushing Device OL-133037, Jetprep Flushing…Jetprep, Ltd. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030765 | Hobbs Mistifier Spray Catheter | Hobbs Medical, Inc. | 2003 | — |
| +1 | K111274 | Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 / PE-105038 /… | Jetprep, Ltd. | 2012 | — |
| +1 | K182319 | Glo-Tip Spray Catheter | Wilson-Cook Medical, Inc. | 2019 | — |
| +2 | 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 | 2 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2022 | Class II | Z-0010-2023 | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a… |
| Jul 29, 2022 | Class II | Z-0011-2023 | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111274 (Jetprep, Ltd., 2012) has gone furthest, with 1 descendant of its own.
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 Hobbs spray catheter is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing or staining mucosal tissue.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030765: Hobbs Mistifier Spray Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030765
Report an extraction error
Are you the manufacturer?
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