K251402 is an FDA 510(k) clearance for the LIA-1 Catheter (542-1). This device is classified as a Bronchoscope Accessory (Class II - Special Controls, product code KTI).
Submitted by Leadoptik, Inc. (San Jose, US). The FDA issued a Cleared decision on December 19, 2025, 227 days after receiving the submission on May 6, 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 | K251402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 227 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). |