FDA product code CAN: Regulator, Pressure, Gas Cylinder
CAN is the FDA product code for regulator, pressure, gas cylinder. It is a Class I device, regulated under 21 CFR 868.2700 and reviewed by the Anesthesiology panel. FDA has cleared 55 510(k) submissions under CAN, from 45 different applicants. The average 510(k) review took 88 days (median 66). FDA has posted 17 recalls for CAN devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Regulator, Pressure, Gas Cylinder |
| Device class | Class I |
| Regulation | 21 CFR 868.2700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for CAN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 147 |
Compare with all 510(k) review times · Search every CAN clearance
Top CAN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Puritan Bennett Corp. | 3 | 1990-01-09 |
| Precision Medical, Inc. | 2 | 1993-10-25 |
| C.G.H. Medical, Inc. | 2 | 1992-05-27 |
| Lifeguard Medical Products, Inc. | 2 | 1992-04-22 |
| Modern Engineering Co., Inc. | 2 | 1989-08-31 |
40 more applicants have CAN clearances. See the full list in Caduvo.
Most recent CAN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162811 | Essex Industries, Inc. | MR Conditional CGA 870 | 2017-03-02 | 147 |
| K080243 | San Cheong Co. , Ltd. | PORTABLE OXYGEN UNIT SCA900 | 2009-04-07 | 432 |
| K060265 | Remcore, Inc. | REMCORE REMOTE CONTROLLED OXYGEN REGULATOR | 2006-10-25 | 266 |
| K061785 | Responsive Respiratory, Inc. | CYL-FIL OXYGEN SYSTEM | 2006-09-07 | 76 |
| K950777 | Mada Medical Products, Inc. | OXYGEN REGULATOR | 1995-04-14 | 52 |
Recalls for CAN devices
17 product recalls in 11 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-01-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code CAN?
CAN is the FDA product code for regulator, pressure, gas cylinder. It is a Class I device, regulated under 21 CFR 868.2700 and reviewed by the Anesthesiology panel.
What device class is CAN?
Class I, regulation 21 CFR 868.2700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CAN?
Across 55 cleared submissions the average was 88 days from receipt to decision (median 66).
Which companies have the most CAN clearances?
Puritan Bennett Corp. (3); Precision Medical, Inc. (2); C.G.H. Medical, Inc. (2); Lifeguard Medical Products, Inc. (2); Modern Engineering Co., Inc. (2).
Have CAN devices been recalled?
Yes: 17 product recalls across 11 recall events; the most recent began 2023-01-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CAN
- Run a recall and safety report across every CAN manufacturer
- Watch product code CAN 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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