510(k) Report

FDA applicant

Shiley, Inc.

Irvine, CA174 decisions1976–199329 recalls

FDA records 174 decisions for Shiley, Inc. (Irvine, CA) from 1976 to 1993: 174 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). 29 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Shiley, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shiley, Inc. since 2007.

Recalls per year

2in 2026

2010: 252020: 22026 (partial year): 2
2007high 25 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Shiley, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass21decisions
  • DTNReservoir, Blood, Cardiopulmonary Bypass14decisions
  • BTOTube, Tracheostomy (W/Wo Connector)13decisions
  • CACApparatus, Autotransfusion11decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass11decisions
  • DTZOxygenator, Cardiopulmonary Bypass10decisions

Also: LFJ (7), DXE (5), DSY (5), BTR (5), KRI (4), DTP (4).

Who builds on its devices?

Later devices cite its devices 49 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K811447Shiley Disposable Cannula Trach. TubeShiley, Inc. · 19816cite it
  • K810106Shiley Single Cannula Tracheostomy TubeShiley, Inc. · 19815cite it
  • K811033Shiley Low Pressure Thin-Cuffed TrachShiley, Inc. · 19814cite it
  • K821993Shiley Laryngectomy TubeShiley, Inc. · 19822cite it
  • K865061Shiley Dispos Cannula Fenes LP Cuffed Trache TubeShiley, Inc. · 19872cite it
  • K880614Shiley Disp. Cannula Cuffless Traceostomy TubeShiley, Inc. · 19882cite it

What has FDA decided for it lately?

  • K920594Shiley Perfusion Tubing SetsShiley, Inc. · 1993
  • K910991Shiley Therapeutic Autotransfusion SystemShiley, Inc. · 1991
  • K911876Shiley Plexus (R) Venous Reservoir, PVR1200Shiley, Inc. · 1991
  • K910923BCD AdvancedShiley, Inc. · 1991
  • K901548Biomedical Sensors-Shiley BGM 4000 Intra Blood GasShiley, Inc. · 1991
  • K903435Shiley Specialized Tracheostomy TubeShiley, Inc. · 199019 recalls
  • K901624Shiley Plexus Integral Reservoir Hollow Fiber Oxy.Shiley, Inc. · 1990
  • K901250Plexus 2(TM) Infant Hollow Fiber OxygenatorShiley, Inc. · 1990

All 174 as Shiley, Inc. →

What has been recalled?

29 recalls linked to its devices; the latest:

  • K843730Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060…Apr 23, 2026Class II
  • K812302COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code…Apr 15, 2026Class II
  • K900753Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert…Apr 24, 2020Class II
  • K900753Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert…Apr 24, 2020Class II
  • K903435Shiley Specialized Tracheostomy Tube, M10SCT, Sterile EO, Made in Mexico, Tyco…Apr 13, 2010
  • K903435Shiley Specialized Tracheostomy Tube, MDCT, Sterile EO, Made in Mexico, Tyco Healthcare…Apr 13, 2010

Other applicant names beginning “Shiley”

FDA records each applicant name separately; these may or may not be the same firm.

Shiley Infusaid, Inc. 3