FDA product code NVP: Holding Chambers, Direct Patient Interface
NVP is the FDA product code for holding chambers, direct patient interface. It is a Class II device, regulated under 21 CFR 868.5630 and reviewed by the Anesthesiology panel. FDA has cleared 16 510(k) submissions under NVP, 2 in the last five years, from 11 different applicants. The average 510(k) review took 247 days (median 234); 132 days on average over the last three years. FDA has posted 3 recalls for NVP devices.
Definition
Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles
Classification
| Field | Value |
|---|---|
| Device name | Holding Chambers, Direct Patient Interface |
| Device class | Class II |
| Regulation | 21 CFR 868.5630 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for NVP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 486 |
| 2019 | 1 | 203 |
| 2022 | 1 | 400 |
| 2025 | 1 | 132 |
Compare with all 510(k) review times · Search every NVP clearance
Top NVP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trudell Medical Intl. | 4 | 2012-07-11 |
| Trudell Medical International | 2 | 2025-01-15 |
| Thayer Medical Corporation | 2 | 2022-04-01 |
| Medical Developments International Limited | 1 | 2016-01-26 |
| Fsc Laboratories, Inc. | 1 | 2014-10-03 |
6 more applicants have NVP clearances. See the full list in Caduvo.
Most recent NVP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242667 | Trudell Medical International | AeroChamber2go Anti-Static Valved Holding Chamber | 2025-01-15 | 132 |
| K210558 | Thayer Medical Corporation | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | 2022-04-01 | 400 |
| K181649 | Trudell Medical International | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | 2019-01-11 | 203 |
| K160109 | Thayer Medical Corporation | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | 2017-05-19 | 486 |
| K143615 | Medical Developments International Limited | Antistatic Compact Space Chamber | 2016-01-26 | 403 |
Recalls for NVP devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2021-03-16.
| Year | Recalls |
|---|---|
| 2021 | 2 |
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 NVP?
NVP is the FDA product code for holding chambers, 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 NVP?
Class II, regulation 21 CFR 868.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVP?
Across 16 cleared submissions the average was 247 days from receipt to decision (median 234).
Which companies have the most NVP clearances?
Trudell Medical Intl. (4); Trudell Medical International (2); Thayer Medical Corporation (2); Medical Developments International Limited (1); Fsc Laboratories, Inc. (1).
Have NVP devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2021-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code NVP
- Run a recall and safety report across every NVP manufacturer
- Watch product code NVP 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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