# K812302: Shiley Fenestrated Low Press. Cuffed

- Pathway: 510(k) (Traditional)
- Applicant: Shiley, Inc.
- Decided: Sep 8, 1981 after 25 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962173: Shikey Tracheostomy Tubes and Accessories (1996), 7 descendants of its own
- K142296: Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula (2015), 3 descendants of its own
- K961449: Tracheostomy Tubes Tracoe-Flex (1996), 3 descendants of its own
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own
- K150844: Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (2015), 1 descendant of its own

## Recalls of this device
- Apr 15, 2026 · Class II · Z-2261-2026: Due to customer complaint regarding incorrect display box labeling.

Source page: https://510kreport.com/device/K812302
Methodology: https://510kreport.com/methodology