# K955645: Cath-Guide

- Pathway: 510(k) (Traditional)
- Applicant: Hudson Respiratory Care, Inc.
- Decided: Mar 12, 1996 after 91 days
- Product code: BSY (Catheters, Suction, Tracheobronchial)
- Device class: 1
- Regulation: 21 CFR 868.6810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K760371 (1976). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872621: Trach Care Catheter, Ballard Medical Products (1987) Summary page 1.
- K902383: Steri-Cath (TM), Concord/Portex (1990) Summary page 1.
- K902687: Steri-Cath-DL, Concord/Portex (1990) Summary page 1.
- K760371: Vent-O2-Cath, Dryden Corp. (1976) Summary page 1.
- (no number) Maxi-Flo Suction Catheter: named in the summary without a submission number
- (no number) Davol Sleeved suction catheter: named in the summary without a submission number

## Indications for use
Patients requiring suctioning of airway secretions

Source page: https://510kreport.com/device/K955645
Methodology: https://510kreport.com/methodology