Cleared Traditional

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230280 · Ga Health Company Limited · Ear, Nose, Throat device
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May 2023
Decision
99d
Days
Class 2
Risk

K230280 is an FDA 510(k) clearance for the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Ga Health Company Limited (Hong Kong, HK). The FDA issued a Cleared decision on May 11, 2023 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Ga Health Company Limited devices

Submission Details

510(k) Number K230280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2023
Decision Date May 11, 2023
Days to Decision 99 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 89d · This submission: 99d
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KTI Bronchoscope Accessory

All 21
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K230280.
Disposable Cytology Brush (AF series)
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K221206 · Serpex Medical, Inc. · Aug 2022
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
K213060 · Micro-Tech (Nanjing) Co., Ltd. · Jul 2022