T-Piece Resuscitator
FDA 510(k) K142096 · Mercury Medical
510(k) numberK142096
Submission
- Device name
- T-Piece Resuscitator
- Applicant
- Mercury Medical
Bonita Springs, FL, US - Received
- August 1, 2014
- Decision date
- October 17, 2014
- 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
Other 510(k)s with product code BTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| 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 |
| K140049 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 05/29/2014SE |
More from Thornhill Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093913 | Mercury Medical T-Piece ResuscitatorBTL · Traditional | 04/06/2010SE |
| K090710 | Mercury CPAPBYE · Traditional | 08/20/2009SE |
| K083056 | Neo-Stat CO2 <KgCCK · Traditional | 02/23/2009SE |
| K032593 | Mercury Medical Negative Inspiratory Force (Nif) Disposable MonometerBXR · Traditional | 02/03/2004SE |
| K031814 | STATCO2METER, Model 10-55372CCK · Traditional | 08/14/2003SE |
| K031411 | Mini STATCO2 CO2 Detector, Model 10-55371CCK · Traditional | 07/30/2003SE |
| K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370CCK · Traditional | 11/04/2002SE |
| K001714 | Mercury Medical Hyperinflation Bag System, Model 83-900-0149NHK · Traditional | 11/03/2000SE |
| K000073 | Mercury Medical Disposable Radiofrequency CannulaGXI · Traditional | 03/01/2000SE |
| K970756 | Mercury Medical Reusable CPR BagBTM · Traditional | 10/31/1997SE |
Questions and answers
When was T-Piece Resuscitator cleared by the FDA?
T-Piece Resuscitator (K142096) received a 510(k) decision of Substantially Equivalent on October 17, 2014, 77 days after the submission was received.
What is the product code of K142096?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.