Cleared Traditional

K241679 - Disposable Cytology Brush (AF series) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241679 · Alton (Shanghai) Medical Instruments Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
266d
Days
Class 2
Risk

K241679 is an FDA 510(k) clearance for the Disposable Cytology Brush (AF series). Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Alton (Shanghai) Medical Instruments Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 4, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alton (Shanghai) Medical Instruments Co., Ltd. devices

Submission Details

510(k) Number K241679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 139d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - KTI Bronchoscope Accessory

All 32
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K241679.
ClearTip TBNA Type
K251478 · Finemedix Co., Ltd. · Apr 2026
LungFlow Basket Catheter
K254040 · Free Flow Medical, Inc. · Mar 2026
LIA-1 Catheter (542-1)
K251402 · Leadoptik, Inc. · Dec 2025
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
K252874 · Serpex Medical, Inc. · Oct 2025
Single Use Aspiration Needle (NA-201SX-4021)
K251664 · Olympus Medical Systems Corporation · Jul 2025
Disposable Grasping Forceps FG-52D/FG-54D
K250263 · Olympus Medical Systems Corp. · Mar 2025