LungFlow Airway Catheter— 510(k) K254037
Substantially EquivalentFree Flow Medical, Inc.
FDA 510(k) clearance K254037 for LungFlow Airway Catheter, Substantially Equivalent on 2026-07-10. Applicant: Free Flow Medical, Inc.. Device class: 2.
Summary
Free Flow Medical's LungFlow Airway Catheter is filed under EOQ, flexible or rigid bronchoscopes. The device name describes a catheter, which the code name doesn't mention, and the record doesn't explain the fit.
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. Review took 206 calendar days (December 16, 2025 to July 10, 2026).
Clearance details
- Applicant
- Free Flow Medical, Inc.
- Product code
- Product code EOQ
- 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
Recent devices under product code EOQ
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- K260309 — Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more
- K260382 — MONARCH Platform (MON-000008)
- K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
More clearances from Free Flow Medical, Inc.
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.