V60 Anesthetic Vaporizer
FDA 510(k) K150167 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) numberK150167
Submission
- Device name
- V60 Anesthetic Vaporizer
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen, CN - Received
- January 26, 2015
- Decision date
- June 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAD – Vaporizer, Anesthesia, Non-Heated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5880
- Specialty
- Anesthesiology
Other 510(k)s with product code CAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240375 | V80 Anesthetic Vaporizer (V80)CAD · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10/31/2024SE |
| K172702 | Tec 820, Tec 850CAD · Traditional | Datex-Ohmeda, Inc. | 01/04/2018SE |
| K110608 | Sevoflurane Vaporizer AdaptorCAD · Traditional | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 07/20/2011SE |
| K060331 | Sigma Alpha VaporizerCAD · Traditional | Penlon Limited | 05/10/2006SE |
| K053564 | Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454CAD · Traditional | Penlon Limited | 03/03/2006SE |
| K051666 | Gav - General Anaesthetic VaporizerCAD · Traditional | General Anaesthetic Services Limited | 08/23/2005SE |
| K042276 | D-VaporCAD · Traditional | Draeger Medical, Inc. | 09/23/2004SE |
| K041076 | Delta TCAD · Special | Penlon , Ltd. | 08/09/2004SE |
| K031027 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)CAD · Special | Datex-Ohmeda, Inc. | 06/26/2003SE |
| K012924 | Datex-Ohmeda Tec 7 Anesthesia VaporizerCAD · Special | Datex-Ohmeda, Inc. | 01/30/2002SE |
More from Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ · Traditional | 06/25/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | 05/20/2026SE |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…IYN · Traditional | 05/11/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | 04/16/2026SE |
| K252182 | SV70 Ventilator (SV70)MNT · Traditional | 04/06/2026SE |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…IYN · Traditional | 02/11/2026SE |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…IYN · Traditional | 12/03/2025SE |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…IYN · Traditional | 11/07/2025SE |
| K251820 | ViewMateTM Ultrasound SystemIYN · Traditional | 09/12/2025SE |
| K251250 | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System…IYN · Traditional | 09/05/2025SE |
Questions and answers
When was V60 Anesthetic Vaporizer cleared by the FDA?
V60 Anesthetic Vaporizer (K150167) received a 510(k) decision of Substantially Equivalent on June 30, 2015, 155 days after the submission was received.
What is the product code of K150167?
The FDA product code is CAD – Vaporizer, Anesthesia, Non-Heated, a Class II (moderate risk) device regulated under 21 CFR 868.5880.