Regulator, Pressure, Cuff
FDA 510(k) K760453 · Boehringer Laboratories
510(k) numberK760453
Submission
- Device name
- Regulator, Pressure, Cuff
- Applicant
- Boehringer Laboratories
Mchenry, IL, US - Received
- August 16, 1976
- Decision date
- September 13, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | 08/14/2026SE |
| K243399 | Boehringer Laboratories Liver RetractorGCJ · Traditional | 07/02/2025SE |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)KNT · Traditional | 05/06/2024SE |
| K234145 | ViSiGi 3D Gastric Sizing TubeKNT · Special | 01/26/2024SE |
| K151990 | Tissue Removal SystemGCJ · Traditional | 09/11/2015SE |
| K150781 | Tissue Removal PouchGCJ · Traditional | 06/19/2015SE |
| K130483 | Boehringer Gastric Sizing TubeKNT · Traditional | 03/28/2013SE |
| K061788 | Boehringer Laboratories Suction Pump SystemOMP · Traditional | 07/11/2006SE |
| K060277 | Boehringer Laboratories Suction Pump SystemJCX · Traditional | 03/03/2006SE |
| K020538 | Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 SeriesDWL · Traditional | 05/15/2002SE |
Questions and answers
When was Regulator, Pressure, Cuff cleared by the FDA?
Regulator, Pressure, Cuff (K760453) received a 510(k) decision of Substantially Equivalent on September 13, 1976, 28 days after the submission was received.
What is the product code of K760453?
The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.