PSV
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ultrasound Bronchoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1550
- Medical specialty
- Radiology
- FDA 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).
- Adverse events (MAUDE)
- 2021: 134 · 2022: 367 · 2023: 717 · 2024: 627 · 2025: 1,491 · 2026: 2,284
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (K183525) | Olympus Medical Systems Corp. | 2019-09-06 |
| OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM (K070983) | Olympus Medical Systems Corporation | 2007-07-05 |
| OLYMPUS BF TYPE UM40 (K021204) | Olympus Optical Co., Ltd. | 2002-05-01 |
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Every clearance here is in the API, with alerts when new ones post.