FDA product code NJK: Valve, Pulmonary
NJK is the FDA product code for valve, pulmonary. It is a Class III device, reviewed by the Anesthesiology panel. Devices under NJK reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 3 recalls for NJK devices, 2 initiated in the last five years.
Definition
To improve lung function in patients with emphysema
Classification
| Field | Value |
|---|---|
| Device name | Valve, Pulmonary |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NJK devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-08-31.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code NJK?
NJK is the FDA product code for valve, pulmonary. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is NJK?
Class III. Typical premarket route: PMA.
Have NJK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2023-08-31.
Next steps
- Run an FDA pathway report with predicate devices for product code NJK
- Run a recall and safety report across every NJK manufacturer
- Watch product code NJK 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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