Atlas FDA

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES

FDA 510(k) clearance K962173 · decided 1996-10-04

Clearance details

K-number
K962173
Device name
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
Applicant
Mallinckrodt Medical
Decision
Substantially Equivalent
Date received
1996-06-05
Decision date
1996-10-04
Days to decision
121 days
Clearance type
Traditional
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
St Louis, MO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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 (K251313)Covidien, LLC2025-12-29
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula (K210833)Smiths Medical Asd, Inc.2021-11-26
TRACOE vario (K203362)Tracoe Medical GmbH2021-08-05
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (K193077)Covidien2020-06-01
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (K193133)Cook Incorporated2019-12-12
Shiley Neonatal/Pediatric Tracheostomy Tube (K182861)Covidien2019-03-22
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (K173912)Smiths Medical Asd, Inc.2018-05-08
Weinmann Tracheostomy Exchange Set (K180034)Cook Incorporated2018-05-07
TRACOE silcosoft Tracheostomy Tube (K172720)Tracoe Medical GmbH2018-04-27
Portex Blue Line Ultra Paediatric Tracheosomy Tube (K170720)Smiths Medical Asd, Inc.2017-12-07
ProTrach Dualcare (K151404)Atos Medical AB2016-02-12
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (K150844)Covidien2015-07-14

Recalls involving this device

RecordFirmDate
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) recall (Z-2174-2012)Nellcor Puritan Bennett Inc. (dba Covidien LP)2012-08-10
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexic recall (Z-1462-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexic recall (Z-1463-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexic recall (Z-1464-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexi recall (Z-1465-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico, Tyco recall (Z-1466-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico, Tyco recall (Z-1467-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico, Tyco recall (Z-1468-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico, Tyc recall (Z-1469-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assem recall (Z-1470-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assem recall (Z-1471-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assem recall (Z-1472-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Asse recall (Z-1473-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, As recall (Z-1476-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, As recall (Z-1477-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare recall (Z-1478-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare recall (Z-1479-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare recall (Z-1480-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare recall (Z-1481-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in M recall (Z-1488-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in M recall (Z-1489-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in M recall (Z-1490-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in recall (Z-1491-2010)Nellcor Puritan Bennett Inc. (dba Covidien Ltd)2010-05-06