Atlas FDA

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

FDA 510(k) clearance K173912 · decided 2018-05-08

Clearance details

K-number
K173912
Device name
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
Applicant
Smiths Medical Asd, Inc.
Decision
Substantially Equivalent
Date received
2017-12-22
Decision date
2018-05-08
Days to decision
137 days
Clearance type
Traditional
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Plymouth, MN, 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
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
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula (K142296)Covidien2015-02-24

Recalls involving this device

RecordFirmDate
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, recall (Z-3086-2024)Smiths Medical ASD Inc.2024-09-11

PMA approvals by this applicant

RecordFirmDate
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018)Smiths Medical Asd, Inc.2013-05-13
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017)Smiths Medical Asd, Inc.2010-04-21
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016)Smiths Medical Asd, Inc.2009-04-20
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015)Smiths Medical Asd, Inc.2007-11-06
PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014)Smiths Medical Asd, Inc.2007-08-28
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013)Smiths Medical Asd, Inc.2007-04-05
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012)Smiths Medical Asd, Inc.2002-12-17
PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011)Smiths Medical Asd, Inc.2002-10-03