LungFlow Basket Catheter— 510(k) K254040
Substantially EquivalentFree Flow Medical, Inc.
FDA 510(k) clearance K254040 for LungFlow Basket Catheter, Substantially Equivalent on 2026-03-12. Applicant: Free Flow Medical, Inc.. Device class: 2.
Summary
Free Flow Medical's LungFlow Basket Catheter is filed under KTI, bronchoscope accessories. The record doesn't list catheter sizes or models.
Class II, 21 CFR 874.4680. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Ear, Nose, and Throat as the classification panel.
Free Flow Medical filed from Fremont, California. The decision came 86 calendar days after receipt (December 16, 2025 to March 12, 2026).
Clearance details
- Applicant
- Free Flow Medical, Inc.
- Product code
- Product code KTI
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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More clearances from Free Flow Medical, Inc.
view allAdverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.