Tracheostomy Cleaning Tray W/Suction Catheter
FDA 510(k) K962078 · Continental Medical Laboratories, Inc.
510(k) numberK962078
Submission
- Device name
- Tracheostomy Cleaning Tray W/Suction Catheter
- Applicant
- Continental Medical Laboratories, Inc.
Waterford, WI, US - Received
- May 28, 1996
- Decision date
- October 11, 1996
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K964827 | Prod. No. 01-132 - Suture Removal KitMCZ · Traditional | 02/14/1997SE |
| K963234 | Staple Removal KitGDT · Traditional | 10/21/1996SE |
| K963443 | Prod. No. 02-031 - Laceration TrayLRO · Traditional | 10/17/1996SE |
| K954728 | Prod No. 01-1694 - 4X4 Foam DressingKMF · Traditional | 09/23/1996SN |
| K962073 | Urethral Catheterization Tray/Universal Urethral Cath TrayFCM · Traditional | 06/21/1996SE |
| K952335 | Wound Care Management KitsLYY · Traditional | 06/14/1995SE |
| K905123 | G-Tube Dressing Change TrayMCY · Traditional | 03/27/1991SE |
Questions and answers
When was Tracheostomy Cleaning Tray W/Suction Catheter cleared by the FDA?
Tracheostomy Cleaning Tray W/Suction Catheter (K962078) received a 510(k) decision of Unknown on October 11, 1996, 136 days after the submission was received.
What is the product code of K962078?
The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.