FDA product code NOU: Continuous, Ventilator, Home Use
NOU is the FDA product code for continuous, ventilator, home use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. FDA has cleared 7 510(k) submissions under NOU, 1 in the last five years, from 4 different applicants. The average 510(k) review took 332 days (median 401); 451 days on average over the last three years. FDA has posted 16 recalls for NOU devices, 6 initiated in the last five years.
Definition
This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
Classification
| Field | Value |
|---|---|
| Device name | Continuous, Ventilator, Home Use |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for NOU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 401 |
| 2025 | 1 | 451 |
Compare with all 510(k) review times · Search every NOU clearance
Top NOU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Breas Medical AB | 3 | 2025-01-13 |
| Respironics California, Inc. | 2 | 2004-03-16 |
| Ge Healthcare, Breas Medical AB | 1 | 2013-06-18 |
| Versamed , Ltd. | 1 | 2003-08-13 |
Most recent NOU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233452 | Breas Medical AB | Vivo 45 LS | 2025-01-13 | 451 |
| K193586 | Breas Medical AB | Vivo 45 LS | 2021-01-27 | 401 |
| K160481 | Breas Medical AB | Vivo 60 | 2016-11-09 | 261 |
| K123144 | Ge Healthcare, Breas Medical AB | VIVO 50 | 2013-06-18 | 256 |
| K034032 | Respironics California, Inc. | PLV CONTINUUM VENTILATOR, MODEL P2000 | 2004-03-16 | 78 |
Recalls for NOU devices
16 product recalls in 10 recall events; 6 initiated in the last five years and 9 still open. Most recent: 2026-03-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NOU?
NOU is the FDA product code for continuous, ventilator, home use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is NOU?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOU?
Across 7 cleared submissions the average was 332 days from receipt to decision (median 401).
Which companies have the most NOU clearances?
Breas Medical AB (3); Respironics California, Inc. (2); Ge Healthcare, Breas Medical AB (1); Versamed , Ltd. (1).
Have NOU devices been recalled?
Yes: 16 product recalls across 10 recall events; the most recent began 2026-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code NOU
- Run a recall and safety report across every NOU manufacturer
- Watch product code NOU 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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