Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251
FDA 510(k) K014102 · Atos Medical AB
510(k) numberK014102
Submission
- Device name
- Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251
- Applicant
- Atos Medical AB
Horby, SE - Received
- December 13, 2001
- Decision date
- February 21, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K151404 | ProTrach DualcareJOH · Traditional | 02/12/2016SE |
| K141380 | Provox Freehands FlexivoiceEWL · Traditional | 09/26/2014SE |
| K131947 | Provox Vega Puncture SetEWL · Traditional | 10/18/2013SE |
| K092593 | Provox Activalve (Size 4.5MM, 6MM, 8MM, 10MM, 12.5MM)EWL · Traditional | 10/14/2010SESK |
| K090455 | Provox Vega, Model 8130-8135EWL · Traditional | 06/05/2009SE |
| K072582 | Provox Micron HmeJOH · Traditional | 05/30/2008SE |
| K043138 | Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134EWL · Special | 11/22/2004SE |
| K022125 | Provox Freehands Hme, Model 7710EWL · Special | 07/30/2002SE |
| K971244 | Provox 2 Voice Prosthesis SystemEWL · Traditional | 06/06/1997SE |
| K942495 | Sinojet Maxillary Sinus Puncture & Irrigation SystemKAM · Traditional | 02/21/1995SE |
Questions and answers
When was Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251 cleared by the FDA?
Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251 (K014102) received a 510(k) decision of Substantially Equivalent on February 21, 2002, 70 days after the submission was received.
What is the product code of K014102?
The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.