FDA product code KHA: Mask, Scavenging
KHA is the FDA product code for mask, scavenging. It is a Class I device, regulated under 21 CFR 868.5590 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under KHA. The average 510(k) review took 81 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Mask, Scavenging |
| Device class | Class I |
| Regulation | 21 CFR 868.5590 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KHA clearance
Top KHA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Accutron, Inc. | 1 | 1997-03-28 |
Most recent KHA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970046 | Accutron, Inc. | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) | 1997-03-28 | 81 |
Recalls for KHA devices
openFDA lists no recalls for product code KHA.
Frequently asked questions
What is FDA product code KHA?
KHA is the FDA product code for mask, scavenging. It is a Class I device, regulated under 21 CFR 868.5590 and reviewed by the Anesthesiology panel.
What device class is KHA?
Class I, regulation 21 CFR 868.5590. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHA?
Across 1 cleared submissions the average was 81 days from receipt to decision (median 81).
Which companies have the most KHA clearances?
Accutron, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KHA
- Run a recall and safety report across every KHA manufacturer
- Watch product code KHA 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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