FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LungFlow Basket Catheter
K Number: K254040
·
Decision Mar 12, 2026
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
32
Applicant Total
1
Review Days
86
Basic Information
- Device Name
- LungFlow Basket Catheter
- K Number
- K254040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Free Flow Medical, Inc.
- Date Received
- December 16, 2025
- Decision Date
- March 12, 2026
- Product Code
- KTI
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KTI | Bronchoscope Accessory | FDA class 2 | Ear, Nose, Throat |
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