Olympus BF Type UM40 Ultrasound Bronchoscope
510(k) K021204
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021204 | Date1 May 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Olympus Bf Type UM40
- 510(k) Number
- FDA Product Code
- PSV
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Olympus BF Type UM40 is an Ultrasound Bronchoscope, classified as a flexible endoscopic device with integrated ultrasonic imaging capabilities. It combines bronchoscope functionality with mechanical scanning to visualize the upper airways, tracheobronchial tree, and adjacent structures in real time. Designed for radiology applications, it serves as an ultrasonic transducer inserted into body cavities, enabling high-resolution imaging of soft tissues and vascular structures. This hybrid device bridges bronchoscopy and ultrasound, facilitating targeted diagnostic procedures.
The Olympus BF Type UM40 is supplied as a reusable medical device, intended for use in controlled clinical environments such as radiology suites or bronchoscopy labs. It operates under FDA 510(k) clearance (K021204) and falls under Class II regulatory classification (PSV product code). The device requires proper sterilization and maintenance per manufacturer guidelines, with no specific MRI safety restrictions noted. Multiple registration numbers (e.g., 3042172882) reflect its distribution and regulatory tracking in the U.S. market.
Other devices from Olympus Optical Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Olympus BF Type UM40 used for?
The Olympus BF Type UM40 is a hybrid ultrasound bronchoscope designed to visualize the upper airways, tracheobronchial tree, and adjacent soft tissues in real time. Its integrated ultrasonic imaging allows clinicians to obtain high-resolution scans of internal structures during bronchoscopy, aiding in precise diagnostic procedures such as identifying vascular structures or assessing airway abnormalities.
Is the Olympus BF Type UM40 a single-use or reusable device?
The Olympus BF Type UM40 is a reusable medical device. It is intended for use in controlled clinical environments like radiology suites or bronchoscopy labs, where it can be sterilized and maintained according to manufacturer guidelines between procedures. Reusability ensures consistent performance while adhering to proper infection control protocols.
What regulatory approvals does the Olympus BF Type UM40 hold?
The Olympus BF Type UM40 holds FDA 510(k) clearance under the reference number K021204, classified as substantially equivalent to a predicate device. It is also assigned multiple registration numbers (e.g., 3042172882) for tracking in the U.S. market and falls under Class II regulatory classification with the product code PSV.
Does the Olympus BF Type UM40 have any MRI safety restrictions?
The Olympus BF Type UM40 does not have specific MRI safety restrictions noted in its documentation. However, standard precautions for endoscopic devices should be followed when used in proximity to MRI equipment, including ensuring compatibility with the imaging environment and adhering to facility guidelines for metallic or electronic devices.
How is the Olympus BF Type UM40 supplied and maintained?
The Olympus BF Type UM40 is supplied as a reusable device intended for use in clinical settings such as radiology suites or bronchoscopy labs. Proper sterilization and maintenance are required per manufacturer guidelines to ensure functionality and safety between uses. This includes cleaning, disinfection, and periodic inspections to maintain device integrity.