FDA product code PSV: Ultrasound Bronchoscope
PSV is the FDA product code for ultrasound bronchoscope. It is a Class II device, regulated under 21 CFR 892.1550 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under PSV, 1 in the last five years, from 3 different applicants. The average 510(k) review took 142 days (median 146); 202 days on average over the last three years. FDA has posted 2 recalls for PSV devices, 2 initiated in the last five years.
Definition
An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound Bronchoscope |
| Device class | Class II |
| Regulation | 21 CFR 892.1550 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for PSV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 261 |
| 2026 | 1 | 202 |
Compare with all 510(k) review times · Search every PSV clearance
Top PSV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Medical Systems Corporation | 2 | 2026-08-27 |
| Olympus Medical Systems Corp. | 1 | 2019-09-06 |
| Olympus Optical Co., Ltd. | 1 | 2002-05-01 |
Most recent PSV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260401 | Olympus Medical Systems Corporation | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | 2026-08-27 | 202 |
| K183525 | Olympus Medical Systems Corp. | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | 2019-09-06 | 261 |
| K070983 | Olympus Medical Systems Corporation | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM | 2007-07-05 | 90 |
| K021204 | Olympus Optical Co., Ltd. | OLYMPUS BF TYPE UM40 | 2002-05-01 | 15 |
Recalls for PSV devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-09-25.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code PSV?
PSV is the FDA product code for ultrasound bronchoscope. It is a Class II device, regulated under 21 CFR 892.1550 and reviewed by the Ear, Nose and Throat panel.
What device class is PSV?
Class II, regulation 21 CFR 892.1550. Typical premarket route: 510(k).
How long does a 510(k) take for product code PSV?
Across 4 cleared submissions the average was 142 days from receipt to decision (median 146).
Which companies have the most PSV clearances?
Olympus Medical Systems Corporation (2); Olympus Medical Systems Corp. (1); Olympus Optical Co., Ltd. (1).
Have PSV devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code PSV
- Run a recall and safety report across every PSV manufacturer
- Watch product code PSV 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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