Cleared Traditional

K241679 - Disposable Cytology Brush (AF series)

K241679 is an FDA 510(k) clearance for Disposable Cytology Brush (AF series), manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. The device is a Class 2 Anesthesiology device with product code KTI cleared through the Traditional 510(k) pathway after a 266-day FDA review.

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

FDA 510(k) Submission Details - K241679

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
126d slower than avg
Panel avg: 140d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTI Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K241679.
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