FDA product code NWA: Prosthesis, Tracheal, Preformed/Molded
NWA is the FDA product code for prosthesis, tracheal, preformed/molded. It is a Class II device, regulated under 21 CFR 878.3720 and reviewed by the Anesthesiology panel. FDA has cleared 7 510(k) submissions under NWA, 3 in the last five years, from 6 different applicants. The average 510(k) review took 138 days (median 99); 26 days on average over the last three years.
Definition
The device is intended to provide support to weakened or constricting airway walls.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Tracheal, Preformed/Molded |
| Device class | Class II |
| Regulation | 21 CFR 878.3720 |
| Review panel | AN — Anesthesiology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NWA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 390 |
| 2022 | 1 | 291 |
| 2024 | 1 | 29 |
| 2026 | 1 | 24 |
Compare with all 510(k) review times · Search every NWA clearance
Top NWA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Novatech SA | 2 | 2024-10-29 |
| VisionAir Solutions | 1 | 2026-06-01 |
| New Cos Inc. Dba Visionair Solutions | 1 | 2022-10-07 |
| New Cos, Inc. | 1 | 2019-10-23 |
| Bryan Corp. | 1 | 1989-10-24 |
1 more applicants have NWA clearances. See the full list in Caduvo.
Most recent NWA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261541 | VisionAir Solutions | VisionAir Enhanced Stock Stent | 2026-06-01 | 24 |
| K243126 | Novatech SA | TRACHEOBRONXANE DUMON® | 2024-10-29 | 29 |
| K213969 | New Cos Inc. Dba Visionair Solutions | VisionAir Patient-Specific Airway Stent | 2022-10-07 | 291 |
| K182743 | New Cos, Inc. | Patient-Specific Airway Stent | 2019-10-23 | 390 |
| K971509 | Novatech SA | ENDOXANE | 1997-08-21 | 118 |
Recalls for NWA devices
openFDA lists no recalls for product code NWA.
Frequently asked questions
What is FDA product code NWA?
NWA is the FDA product code for prosthesis, tracheal, preformed/molded. It is a Class II device, regulated under 21 CFR 878.3720 and reviewed by the Anesthesiology panel.
What device class is NWA?
Class II, regulation 21 CFR 878.3720. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWA?
Across 7 cleared submissions the average was 138 days from receipt to decision (median 99).
Which companies have the most NWA clearances?
Novatech SA (2); VisionAir Solutions (1); New Cos Inc. Dba Visionair Solutions (1); New Cos, Inc. (1); Bryan Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NWA
- Run a recall and safety report across every NWA manufacturer
- Watch product code NWA 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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