Cleared Special

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

K252874 · Serpex Medical, Inc. · Anesthesiology

Oct 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K252874 is an FDA 510(k) clearance for the Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01, 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 review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K252874 FDA.gov
FDA Decision	Cleared 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

Device Classification

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).