FDA product code CAD: Vaporizer, Anesthesia, Non-Heated
CAD is the FDA product code for vaporizer, anesthesia, non-heated. It is a Class II device, regulated under 21 CFR 868.5880 and reviewed by the Anesthesiology panel. FDA has cleared 57 510(k) submissions under CAD, 1 in the last five years, from 31 different applicants. The average 510(k) review took 119 days (median 86); 267 days on average over the last three years. FDA has posted 13 recalls for CAD devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Vaporizer, Anesthesia, Non-Heated |
| Device class | Class II |
| Regulation | 21 CFR 868.5880 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CAD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 119 |
| 2024 | 1 | 267 |
Compare with all 510(k) review times · Search every CAD clearance
Top CAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Draeger Medical, Inc. | 7 | 2004-09-23 |
| Datex-Ohmeda, Inc. | 6 | 2018-01-04 |
| Penlon , Ltd. | 5 | 2004-08-09 |
| Southmedic, Inc. | 5 | 1995-02-22 |
| Ohmeda Medical | 3 | 1995-03-30 |
26 more applicants have CAD clearances. See the full list in Caduvo.
Most recent CAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240375 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | V80 Anesthetic Vaporizer (V80) | 2024-10-31 | 267 |
| K172702 | Datex-Ohmeda, Inc. | Tec 820, Tec 850 | 2018-01-04 | 119 |
| K150167 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | V60 Anesthetic Vaporizer | 2015-06-30 | 155 |
| K110608 | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | SEVOFLURANE VAPORIZER ADAPTOR | 2011-07-20 | 139 |
| K060331 | Penlon Limited | SIGMA ALPHA VAPORIZER | 2006-05-10 | 90 |
Recalls for CAD devices
13 product recalls in 7 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-11-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 5 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code CAD?
CAD is the FDA product code for vaporizer, anesthesia, non-heated. It is a Class II device, regulated under 21 CFR 868.5880 and reviewed by the Anesthesiology panel.
What device class is CAD?
Class II, regulation 21 CFR 868.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAD?
Across 57 cleared submissions the average was 119 days from receipt to decision (median 86).
Which companies have the most CAD clearances?
Draeger Medical, Inc. (7); Datex-Ohmeda, Inc. (6); Penlon , Ltd. (5); Southmedic, Inc. (5); Ohmeda Medical (3).
Have CAD devices been recalled?
Yes: 13 product recalls across 7 recall events; the most recent began 2025-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code CAD
- Run a recall and safety report across every CAD manufacturer
- Watch product code CAD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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