Panels › Anesthesiology › Product code JOH · Class 2
Tube Tracheostomy And Tube Cuff
Regulation 868.5800
1510(k)s in 12 months (109 all time)
5recalls in 12 months (131 all time)
114recalls that name a 510(k)
Top companies in JOH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2026 | Covidien LLC COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN
UDI-DI code: 60884522007028
The devices are intended for use in providing tracheal access for airway management. Shiley Tracheost Open, Classified |
JOH | K812302 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 Open, Classified |
JOH | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092;
Reference Part Number C-PTIS-100-HC, Order Number G12115. Open, Classified |
JOH | K133597 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703;
Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Numbe Open, Classified |
JOH | K193133 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685;
Reference Part Number C-PTIS-100-HC-G-NA, Order Number G5768 Open, Classified |
JOH | K193133 |
| Mar 25, 2025 | Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R Open, Classified |
JOH | K150844 |
| Oct 31, 2023 | Smiths Medical ASD Inc. Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. Open, Classified |
JOH | K083641 |
| May 10, 2023 | Cook Incorporated Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721 Open, Classified |
JOH | K193133 |
| May 10, 2023 | Cook Incorporated Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PT Open, Classified |
JOH | K193133 |
| Apr 19, 2023 | Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:
Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):
10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;
10CN Open, Classified |
JOH | K142296 K150844 |
| May 14, 2021 | Smiths Medical ASD Inc. PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance Terminated |
JOH | K041348 |
| Jan 18, 2021 | Smiths Medical ASD Inc. Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to pro Terminated |
JOH | K944178 |
| Dec 15, 2020 | Smiths Medical ASD Inc. PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 Terminated |
JOH | K944178 |
| Aug 28, 2020 | Smiths Medical ASD Inc. Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube
This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single Terminated |
JOH | K083641 K914088 |
| May 26, 2020 | Smiths Medical ASD Inc. Pediatric Adjustable Flange Tracheostomy Tube Cuffless Terminated |
JOH | K081440 |
| Aug 14, 2017 | Smiths Medical ASD Inc. UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ
The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube t Terminated |
JOH | K962175 |
| Feb 9, 2017 | Smiths Medical ASD Inc. Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035. Terminated |
JOH | K083641 |
| Oct 18, 2016 | Teleflex Medical Willy Rusch GmbH Tracheostomy Tube Set
Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short te Terminated |
JOH | K964056 |
| Jul 15, 2016 | Smiths Medical ASD, Inc. Custom Made Tracheostomy Device
The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag. Terminated |
JOH | None listed |
| Jul 9, 2015 | Covidien LP (formerly Nellcor Puritan Bennett Inc.) Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff.
Intended for use in providing tracheal access for airway managements. Terminated |
JOH | K122531 |
| Jul 9, 2015 | Covidien LP (formerly Nellcor Puritan Bennett Inc.) Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6 Terminated |
JOH | K142298 |
| Aug 10, 2012 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S.
Product Usage: The product is intended for use Terminated |
JOH | K962173 |
| Mar 21, 2012 | Customed, Inc Tracheotomy care kit, catalog# 900-110 Terminated |
JOH | K925020 |
| Jun 29, 2011 | Teleflex Medical RUSCH Percutwist Set with Crystal Clear Sterile
Crystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway. Terminated |
JOH | K023918 |
| Jun 29, 2011 | Teleflex Medical RUSCH Crystal Clear PDT, Sterile
Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway. Terminated |
JOH | None listed |
| Jun 29, 2011 | Teleflex Medical RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack
Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway. Terminated |
JOH | K023918 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51972, C-PTBSYJC-2800-PERC8. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G49507, C-PTBSY-2800-PERC8. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36117, C-PTBS-2800-PERC8. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51971, C-PTBSYJC-2600-PERC6. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36118, C-PTBSY-2600-PERC6. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36116, C-PTBS-2600-PERC6. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC8, G53170. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC6, G53169. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-G-PERC6, G53178. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC8, G12565. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8-CA, G36038. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8, G12523. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6-CA, G36037. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6, G13165. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-A-HC-PERC8, G12566. Terminated |
JOH | K093469 |
| Jul 26, 2010 | Cook, Inc. Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403. Terminated |
JOH | K093469 |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M8DCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, Terminated |
JOH | K903435 |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M6DCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, Terminated |
JOH | K903435 |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, MDCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, p Terminated |
JOH | K903435 |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M8LPC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, Terminated |
JOH | K903435 |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M6LPC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, Terminated |
JOH | K903435 |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, MLPC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, p Terminated |
JOH | K903435 |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M8FEN, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, Terminated |
JOH | K903435 |
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