# K945513: Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Jan 13, 1995 after 65 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.
11 later devices descend from it; 2 cite it directly.
5 of 12 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
- K122531: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T (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
- K251313: Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT (2025), 0 descendants of its own

## Recalls of this device
- Jan 14, 2009 · Not classified · Z-0997-2009: Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.

Source page: https://510kreport.com/device/K945513
Methodology: https://510kreport.com/methodology