K252874 is an FDA 510(k) clearance for the Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01. This device is classified as a Bronchoscope Accessory (Class II - Special Controls, product code KTI).
Submitted by Serpex Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 8, 2025, 28 days after receiving the submission on September 10, 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 | K252874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2025 |
| Decision Date | October 08, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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). |