Shiley Flextra Tracheostomy Tube
FDA 510(k) K030787 · Nellcor Puritan Bennett, Inc.
510(k) numberK030787
Submission
- Device name
- Shiley Flextra Tracheostomy Tube
- Applicant
- Nellcor Puritan Bennett, Inc.
Pleasanton, CA, US - Received
- March 12, 2003
- Decision date
- November 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOH – Tube Tracheostomy And Tube Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5800
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code JOH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with…JOH · Traditional | Covidien, LLC | 12/29/2025SE |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…JOH · Traditional | Smiths Medical Asd, Inc. | 11/26/2021SE |
| K203362 | TRACOE varioJOH · Traditional | Tracoe Medical GmbH | 08/05/2021SE |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffJOH · Traditional | Covidien | 06/01/2020SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | Cook Incorporated | 12/12/2019SE |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy TubeJOH · Traditional | Covidien | 03/22/2019SE |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional | Smiths Medical Asd, Inc. | 05/08/2018SE |
| K180034 | Weinmann Tracheostomy Exchange SetJOH · Traditional | Cook Incorporated | 05/07/2018SE |
| K172720 | TRACOE silcosoft Tracheostomy TubeJOH · Traditional | Tracoe Medical GmbH | 04/27/2018SE |
| K170720 | Portex Blue Line Ultra Paediatric Tracheosomy TubeJOH · Traditional | Smiths Medical Asd, Inc. | 12/07/2017SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070899 | Puritan Bennett Legendair XL2CBK · Traditional | 12/13/2007SE |
| K070408 | Duramax Reusable Oximetry SensorDQA · Abbreviated | 05/25/2007SE |
| K060576 | Nellcor Oximax N-600X Pulse OximeterDQA · Traditional | 08/14/2006SE |
| K051271 | Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorDQA · Traditional | 01/10/2006SE |
| K052186 | Nellcor Oximax Pulse Oximetry Sensons (Max-A, Max-Al, Max-N, Max-I, Max-PDQA · Special | 11/10/2005SE |
| K051352 | Oximax NPB-40 Handheld Pulse OximeterDQA · Traditional | 08/11/2005SE |
| K050072 | Goodknight 425STBZD · Special | 06/13/2005SE |
| K033973 | Oxisensor II Recycled Sensor and Oximax Recycled SensorNLF · Traditional | 12/13/2004SE |
| K030930 | Oximax Softcare Sensors, Models Sc-A, Sc-Pr, Sc-Neo, Sc-NDQA · Traditional | 05/23/2003SE |
| K023494 | Nellcor Indgo Manual ResuscitatorBTM · Special | 02/07/2003SE |
Questions and answers
When was Shiley Flextra Tracheostomy Tube cleared by the FDA?
Shiley Flextra Tracheostomy Tube (K030787) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 247 days after the submission was received.
What is the product code of K030787?
The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.