FDA product code PCM: Portable Liquid Oxygen Unit Stand
PCM is the FDA product code for portable liquid oxygen unit stand. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under PCM. The average 510(k) review took 205 days (median 205).
Definition
To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.
Classification
| Field | Value |
|---|---|
| Device name | Portable Liquid Oxygen Unit Stand |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PCM clearance
Top PCM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Assist Fill, LLC | 1 | 2012-12-27 |
Most recent PCM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121661 | Assist Fill, LLC | EZ-ASSIST-FILL | 2012-12-27 | 205 |
Recalls for PCM devices
openFDA lists no recalls for product code PCM.
Frequently asked questions
What is FDA product code PCM?
PCM is the FDA product code for portable liquid oxygen unit stand. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Anesthesiology panel.
What device class is PCM?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PCM?
Across 1 cleared submissions the average was 205 days from receipt to decision (median 205).
Which companies have the most PCM clearances?
Assist Fill, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCM
- Run a recall and safety report across every PCM manufacturer
- Watch product code PCM 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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