K254040 is an FDA 510(k) clearance for the LungFlow Basket Catheter. This device is classified as a Bronchoscope Accessory (Class II - Special Controls, product code KTI).
Submitted by Free Flow Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on March 12, 2026, 86 days after receiving the submission on December 16, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 874.4680. 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)..
| 510(k) Number | K254040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KTI — Bronchoscope Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| Definition | 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). |