# K972385: Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: Jan 20, 1998 after 208 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Flexible D.I.C. Tracheostomy Tube: named in the summary without a submission number
- (no number) Fenestrated Blue Line Tracheostomy Tube: named in the summary without a submission number
- (no number) Fenestrated D.I.C. Tracheostomy Tube: named in the summary without a submission number
- (no number) Shiley’s fenestrated low pressure cuffed tracheostomy tube: named in the summary without a submission number
- (no number) Boston Medical Products’ Tracoe fenestrated tracheostomy tube: named in the summary without a submission number

## Most influential descendants
- K062104: Talking Trach (2007), 0 descendants of its own

## Indications for use
The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventilation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.

Source page: https://510kreport.com/device/K972385
Methodology: https://510kreport.com/methodology