# K030765: Hobbs Mistifier Spray Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hobbs Medical, Inc.
- Decided: Jun 9, 2003 after 90 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111274: Jetprep Flushing Device OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 (2012), 1 descendant of its own
- K182319: Glo-Tip Spray Catheter (2019), 0 descendants of its own
- K122740: Jetprep Flushing Device OL-103037, Jetprep Flushing Device OL-133037, Jetprep Flushing Device OL-168037, Jetprep Flushin (2012), 0 descendants of its own

## Recalls of this device
- Jul 29, 2022 · Class II · Z-0010-2023: 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 2022-1
- Jul 29, 2022 · Class II · Z-0011-2023: 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 2022-1

## Indications for use
The Hobbs spray catheter is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing or staining mucosal tissue.

Source page: https://510kreport.com/device/K030765
Methodology: https://510kreport.com/methodology