FDA product code OCR: Lung Sound Monitor
OCR is the FDA product code for lung sound monitor. It is a Class II device, regulated under 21 CFR 870.1875 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under OCR. The average 510(k) review took 326 days (median 300).
Definition
The lung sound monitor is intended for use in monitoring and recording lung sounds.
Classification
| Field | Value |
|---|---|
| Device name | Lung Sound Monitor |
| Device class | Class II |
| Regulation | 21 CFR 870.1875 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OCR clearance
Top OCR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Deep Breeze , Ltd. | 3 | 2010-03-04 |
Most recent OCR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091732 | Deep Breeze , Ltd. | VRLXP, MODEL XP | 2010-03-04 | 266 |
| K073582 | Deep Breeze , Ltd. | VRIICU SYSTEM | 2008-10-15 | 300 |
| K061495 | Deep Breeze , Ltd. | VR LUNG ELECTROSONOGRAPH | 2007-07-18 | 413 |
Recalls for OCR devices
openFDA lists no recalls for product code OCR.
Frequently asked questions
What is FDA product code OCR?
OCR is the FDA product code for lung sound monitor. It is a Class II device, regulated under 21 CFR 870.1875 and reviewed by the Anesthesiology panel.
What device class is OCR?
Class II, regulation 21 CFR 870.1875. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OCR?
Across 3 cleared submissions the average was 326 days from receipt to decision (median 300).
Which companies have the most OCR clearances?
Deep Breeze , Ltd. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code OCR
- Run a recall and safety report across every OCR manufacturer
- Watch product code OCR 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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