FDA product code NHP: Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHP is the FDA product code for analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration). It is a Class II device, regulated under 21 CFR 868.1500 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under NHP. The average 510(k) review took 77 days (median 77).
Definition
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class II |
| Regulation | 21 CFR 868.1500 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NHP clearance
Top NHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Draeger Medical Systems, Inc. | 1 | 2004-04-14 |
Most recent NHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040188 | Draeger Medical Systems, Inc. | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE | 2004-04-14 | 77 |
Recalls for NHP devices
openFDA lists no recalls for product code NHP.
Frequently asked questions
What is FDA product code NHP?
NHP is the FDA product code for analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration). It is a Class II device, regulated under 21 CFR 868.1500 and reviewed by the Anesthesiology panel.
What device class is NHP?
Class II, regulation 21 CFR 868.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHP?
Across 1 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most NHP clearances?
Draeger Medical Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NHP
- Run a recall and safety report across every NHP manufacturer
- Watch product code NHP 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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