FDA product code NVO: Spacer, Direct Patient Interface
NVO is the FDA product code for spacer, direct patient interface. It is a Class II device, regulated under 21 CFR 868.5630 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under NVO. The average 510(k) review took 120 days (median 120).
Definition
Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles.
Classification
| Field | Value |
|---|---|
| Device name | Spacer, Direct Patient Interface |
| Device class | Class II |
| Regulation | 21 CFR 868.5630 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Top NVO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmacaribe | 2 | 2010-09-01 |
Most recent NVO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101532 | Pharmacaribe | NESSI OTC SPACER | 2010-09-01 | 90 |
| K091862 | Pharmacaribe | NESSI SPACER | 2009-11-20 | 150 |
Recalls for NVO devices
openFDA lists no recalls for product code NVO.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0379 — Direct admission of patient for hospital observation care
Frequently asked questions
What is FDA product code NVO?
NVO is the FDA product code for spacer, direct patient interface. It is a Class II device, regulated under 21 CFR 868.5630 and reviewed by the Anesthesiology panel.
What device class is NVO?
Class II, regulation 21 CFR 868.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVO?
Across 2 cleared submissions the average was 120 days from receipt to decision (median 120).
Which companies have the most NVO clearances?
Pharmacaribe (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NVO
- Run a recall and safety report across every NVO manufacturer
- Watch product code NVO 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.