FDA product code PNV: Impedance Measuring Device Utilizing Oscillation Techniques
PNV is the FDA product code for impedance measuring device utilizing oscillation techniques. It is a Class II device, regulated under 21 CFR 868.1840 and reviewed by the Anesthesiology panel. FDA has cleared 4 510(k) submissions under PNV, 1 in the last five years, from 3 different applicants. The average 510(k) review took 302 days (median 268).
Definition
This device measures respiratory impedance.
Classification
| Field | Value |
|---|---|
| Device name | Impedance Measuring Device Utilizing Oscillation Techniques |
| Device class | Class II |
| Regulation | 21 CFR 868.1840 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for PNV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 232 |
| 2020 | 1 | 247 |
| 2023 | 1 | 440 |
Compare with all 510(k) review times · Search every PNV clearance
Top PNV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thorasys Thoracic Medical Systems, Inc. | 2 | 2023-06-20 |
| Cognita Labs, LLC | 1 | 2020-03-18 |
| Medical Graphics Corp. | 1 | 2016-06-24 |
Most recent PNV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221024 | Thorasys Thoracic Medical Systems, Inc. | tremoflo C2 Airwave Oscillometry System | 2023-06-20 | 440 |
| K191876 | Cognita Labs, LLC | PulmoScan | 2020-03-18 | 247 |
| K170185 | Thorasys Thoracic Medical Systems, Inc. | tremoFlo C-100 Airwave Oscillometry System | 2017-09-12 | 232 |
| K152585 | Medical Graphics Corp. | Resmon PRO FULL | 2016-06-24 | 288 |
Recalls for PNV devices
openFDA lists no recalls for product code PNV.
Frequently asked questions
What is FDA product code PNV?
PNV is the FDA product code for impedance measuring device utilizing oscillation techniques. It is a Class II device, regulated under 21 CFR 868.1840 and reviewed by the Anesthesiology panel.
What device class is PNV?
Class II, regulation 21 CFR 868.1840. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNV?
Across 4 cleared submissions the average was 302 days from receipt to decision (median 268).
Which companies have the most PNV clearances?
Thorasys Thoracic Medical Systems, Inc. (2); Cognita Labs, LLC (1); Medical Graphics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PNV
- Run a recall and safety report across every PNV manufacturer
- Watch product code PNV 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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