Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
FDA 510(k) clearance K192511 · decided 2020-07-22
Clearance details
- K-number
- K192511
- Device name
- Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
- Applicant
- Venner Medical (Singapore) Pte, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-12
- Decision date
- 2020-07-22
- Days to decision
- 314 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Singapore, SG
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (K242921) | Vitaltec Corporation | 2025-06-10 |
| Pilling Tracheostomy Tubes (K233713) | Teleflex Medical | 2024-03-22 |
| BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (K173384) | Smiths Medical Ads, Inc. | 2018-04-10 |
| PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (K120079) | Primed Halberstadt Medizintechnik GmbH | 2012-05-24 |
| WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K101721) | Regulatory and Marketing Services, Inc. | 2011-03-24 |
| VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (K100950) | Venner Medical (Singapore) Pte, Ltd. | 2010-07-13 |
| ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (K100480) | Vitaltec Corporation | 2010-06-11 |
| VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC (K100283) | Cook, Inc. | 2010-04-23 |
| PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (K083031) | Smiths Medical Asd, Inc. | 2009-08-18 |
| PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR (K073702) | Lazarus Medical, LLC | 2008-06-26 |
| TALKING TRACH (K062104) | Engineered Medical Systems, Inc. | 2007-04-20 |
| PORTEX PERCUTANEOUS TRACHEOSTOMY KIT (K060945) | Smiths Medical International | 2006-06-19 |
Recalls involving this device
No recalls on record reference this clearance.