CAD · Vaporizer, Anesthesia, Non-Heated
Anesthesiology · 21 CFR 868.5880 · Class 2
Overview
| Product Code | CAD |
|---|---|
| Device Name | Vaporizer, Anesthesia, Non-Heated |
| Regulation | 21 CFR 868.5880 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 31, 2024 | SESE |
| K172702 | Tec 820, Tec 850 | Datex-Ohmeda, Inc. | Jan 4, 2018 | SESE |
| K150167 | V60 Anesthetic Vaporizer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jun 30, 2015 | SESE |
| K110608 | SEVOFLURANE VAPORIZER ADAPTOR | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | Jul 20, 2011 | SESE |
| K060331 | SIGMA ALPHA VAPORIZER | Penlon Limited | May 10, 2006 | SESE |
| K053564 | KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 | Penlon Limited | Mar 3, 2006 | SESE |
| K051666 | GAV - GENERAL ANAESTHETIC VAPORIZER | General Anaesthetic Services Limited | Aug 23, 2005 | SESE |
| K042276 | D-VAPOR | Draeger Medical, Inc. | Sep 23, 2004 | SESE |
| K041076 | DELTA T | Penlon , Ltd. | Aug 9, 2004 | SESE |
| K031027 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) | Datex-Ohmeda, Inc. | Jun 26, 2003 | SESE |
| K012924 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER | Datex-Ohmeda, Inc. | Jan 30, 2002 | SESE |
| K002343 | SIGMA DELTA | Penlon , Ltd. | Jun 8, 2001 | SESE |
| K002878 | DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER | Datex-Ohmeda, Inc. | Sep 21, 2000 | SESE |
| K000275 | DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA | Datex-Ohmeda, Inc. | Apr 12, 2000 | SESE |
| K990132 | DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC | Datex-Ohmeda, Inc. | Jan 21, 1999 | SESE |
| K980489 | VAPAMASTA 6 | Medical Industrial Equipment | Aug 31, 1998 | SESE |
| K980884 | SIEMENS SEVOFLURANE VAPORIZER SV 953 | Siemens Medical Solutions USA, Inc. | Aug 19, 1998 | SESE |
| K981773 | DRAGER-VAPOR 19.3 | Draeger Medical, Inc. | Jul 6, 1998 | SESE |
| K981472 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS | Draeger Medical, Inc. | May 7, 1998 | SESE |
| K973051 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS | Draeger Medical, Inc. | Oct 30, 1997 | SESE |
Top Applicants
- Draeger Medical, Inc. — 7 clearances
- Datex-Ohmeda, Inc. — 6 clearances
- Penlon , Ltd. — 5 clearances
- Southmedic, Inc. — 5 clearances
- Ohmeda Medical — 3 clearances
