# K962173: Shikey Tracheostomy Tubes and Accessories - Pathway: 510(k) (Traditional) - Applicant: Mallinckrodt Medical - Decided: Oct 4, 1996 after 121 days - Product code: JOH (Tube Tracheostomy And Tube Cuff) - Device class: 2 - Regulation: 21 CFR 868.5800 - Recalls of this device: 23 (1 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K792222 (1979). 10 ancestors in all. 7 later devices descend from it; 5 cite it directly. 3 of 18 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K792222: Shiley Low Pressure Thin-Cuffed Trach., Shiley, Inc. (1979) Summary page 1. - K811033: Shiley Low Pressure Thin-Cuffed Trach, Shiley, Inc. (1981) Summary page 1. - K812302: Shiley Fenestrated Low Press. Cuffed, Shiley, Inc. (1981) Summary page 1. - K821993: Shiley Laryngectomy Tube, Shiley, Inc. (1982) Summary page 1. - K811447: Shiley Disposable Cannula Trach. Tube, Shiley, Inc. (1981) Summary page 1. - K843729: Shiley Dispos. Cannula Fenestrated Low, Shiley, Inc. (1984) Summary page 1. - K865061: Shiley Dispos Cannula Fenes LP Cuffed Trache Tube, Shiley, Inc. (1987) Summary page 1. - K880614: Shiley Disp. Cannula Cuffless Traceostomy Tube, Shiley, Inc. (1988) Summary page 1. - K945513: Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy Tube, Mallinckrodt Medical (1995) Summary page 1. - K810106: Shiley Single Cannula Tracheostomy Tube, Shiley, Inc. (1981) Summary page 1. - (no number) Shiley Cuffless Tracheostomy Tubes: named in the summary without a submission number ## 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 - K062104: Talking Trach (2007), 0 descendants of its own ## Recalls of this device - Jul 18, 2012 · Class I · Z-2174-2012: Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical - Apr 13, 2010 · Not classified · Z-1473-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1468-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1491-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1489-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1464-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1462-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1480-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1466-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1465-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1476-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1481-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1472-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1477-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1467-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1490-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1463-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1478-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1470-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1479-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1469-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1488-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. - Apr 13, 2010 · Not classified · Z-1471-2010: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. ## Indications for use The intended use of the modified devices with continue to be provision of tracheal access for airway management in adults. Source page: https://510kreport.com/device/K962173 Methodology: https://510kreport.com/methodology