SafeT T-Piece Resuscitator
FDA 510(k) K173373 · Ventlab, LLC
510(k) numberK173373
Submission
- Device name
- SafeT T-Piece Resuscitator
- Applicant
- Ventlab, LLC
Grand Rapids, MI, US - Received
- October 27, 2017
- Decision date
- November 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
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| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
| K140049 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 05/29/2014SE |
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| K093525 | Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult…CCK · Special | 12/10/2009SE |
| K090840 | Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn.CAF · Traditional | 06/25/2009SE |
| K082204 | Series Sy Disposable Electrosurgical PadODR · Traditional | 08/13/2008SE |
| K063813 | Ventlab Nasal CO2 SAMPLING/O2 Delivery CannulaCCK · Traditional | 03/26/2008SE |
| K040726 | Ventlab Nasal CPAP CannulaBZD · Traditional | 06/03/2004SE |
| K030271 | Ventlab Bacterial Filter, Model BF100CAH · Traditional | 07/07/2003SE |
| K020281 | Modification to Ventlab Hyperinflation Bag SystemNHK · Special | 02/11/2002SE |
Questions and answers
When was SafeT T-Piece Resuscitator cleared by the FDA?
SafeT T-Piece Resuscitator (K173373) received a 510(k) decision of Substantially Equivalent on November 16, 2018, 385 days after the submission was received.
What is the product code of K173373?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.