# K963732: Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Jun 26, 1997 after 282 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810106 (1981). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811447: Shiley Disposable Cannula Trach. Tube, Shiley, Inc. (1981) Summary page 1.
- K810106: Shiley Single Cannula Tracheostomy Tube, Shiley, Inc. (1981) Summary page 1.

## Most influential descendants
- 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
- 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
- K193077: Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (2020), 0 descendants of its own
- K030787: Shiley Flextra Tracheostomy Tube (2003), 0 descendants of its own

## Recalls of this device
- Apr 13, 2010 · Not classified · Z-1475-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Apr 13, 2010 · Not classified · Z-1474-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

## Indications for use
1. This device-is osed-to-orovide*an-artificial-airway ir-order-to-assist in the treatment of a variety of respiratory diseases and airway management for adult patients. 2. The device is to be used by the order of a nhysician. 3. The device is primarily intended for use in conjunction with Percutaneous Dilational (or Dilatational) Tracheotomy and is inserted into the natient using the Introducer orovided with the Percutaneous Dilational Kit. 4. The device is intended to be used as the initial artificial airway immediately post tracheotomy. 5. There is no "new" intended theraneutic use of this device to existing devices marketed.

Source page: https://510kreport.com/device/K963732
Methodology: https://510kreport.com/methodology