Cleared Traditional

Disposable Cytology Brush (AF series)

K241679 · Alton (Shanghai) Medical Instruments Co., Ltd. · Anesthesiology

Mar 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K241679 is an FDA 510(k) clearance for the Disposable Cytology Brush (AF series), a Bronchoscope Accessory (Class II — Special Controls, product code KTI), submitted by Alton (Shanghai) Medical Instruments Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 4, 2025, 266 days after receiving the submission on June 11, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K241679 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2024
Decision Date	March 04, 2025
Days to Decision	266 days
Submission Type	Traditional
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).