# Shiley, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 174 (1976–1993): 174 510(k) clearances
- Product codes: DWF (21), DTN (14), BTO (13), CAC (11), DTR (11), DTZ (10), LFJ (7), DXE (5), DSY (5), BTR (5), KRI (4), DTP (4)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 49 (0 its own)
- Recalls linked to its devices: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Mallinckrodt Medical: 15 (https://510kreport.com/company/mallinckrodt-medical)
- Tracoe Medical GmbH: 7 (https://510kreport.com/company/tracoe-medical)
- Sorin Group Italia S.R.L.: 3 (https://510kreport.com/company/sorin-group-italia)
- Nellcor Puritan Bennett, Inc.: 3 (https://510kreport.com/company/nellcor-puritan-bennett)
- Dideco S.P.A.: 3 (https://510kreport.com/company/dideco)
- Quest Medical, Inc.: 3 (https://510kreport.com/company/quest-medical)
- Portex, Inc.: 2 (https://510kreport.com/company/portex)
- Sorin Biomedical, Inc.: 2 (https://510kreport.com/company/sorin-biomedical)

## Its most-cited devices
- K811447: Shiley Disposable Cannula Trach. Tube (1981), cited by 6
- K810106: Shiley Single Cannula Tracheostomy Tube (1981), cited by 5
- K811033: Shiley Low Pressure Thin-Cuffed Trach (1981), cited by 4
- K821993: Shiley Laryngectomy Tube (1982), cited by 2
- K865061: Shiley Dispos Cannula Fenes LP Cuffed Trache Tube (1987), cited by 2
- K880614: Shiley Disp. Cannula Cuffless Traceostomy Tube (1988), cited by 2

## Recent decisions
- K920594: Shiley Perfusion Tubing Sets (Mar 18, 1993)
- K910991: Shiley Therapeutic Autotransfusion System (Nov 27, 1991)
- K911876: Shiley Plexus (R) Venous Reservoir, PVR1200 (Aug 9, 1991)
- K910923: BCD Advanced (Apr 9, 1991)
- K901548: Biomedical Sensors-Shiley BGM 4000 Intra Blood Gas (Jan 14, 1991)
- K903435: Shiley Specialized Tracheostomy Tube (Oct 2, 1990)
- K901624: Shiley Plexus Integral Reservoir Hollow Fiber Oxy. (Jul 3, 1990)
- K901250: Plexus 2(TM) Infant Hollow Fiber Oxygenator (Jun 11, 1990)

Source page: https://510kreport.com/company/shiley