Cleared Traditional

K220126 - Geonic Nasal Aspirator

K220126 is an FDA 510(k) clearance for Geonic Nasal Aspirator, manufactured by Geon Corporation. The device is a Class 2 Ear, Nose, Throat device with product code BTA cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K220126 · Geon Corporation · Ear, Nose, Throat device
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Feb 2023
Decision
380d
Days
Class 2
Risk

K220126 is an FDA 510(k) clearance for the Geonic Nasal Aspirator, Geonic Nasal Cleaner. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Geon Corporation (Hsi Hu, Chang Hwa Hsien, TW). The FDA issued a Cleared decision on February 2, 2023 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 878.4780 - 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. Elevated predicate reliance profile. 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 Geon Corporation devices

FDA 510(k) Submission Details - K220126

510(k) Number K220126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2022
Decision Date February 02, 2023
Days to Decision 380 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
291d slower than avg
Panel avg: 89d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 Consultant

Alfabeta Clinical Research Co., Ltd.
Wan-Chi Chang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 68
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K220126.
SOMAVAC® 100 Sustained Vacuum System
K231063 · Somavac Medical Solutions, Inc. · May 2023
Renova RP Centesis Pump
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Enivo™
K223373 · Aroa Biosurgery , Ltd. · Apr 2023
Electric nasal aspirator
K222547 · Shenzhen Xinlianfeng Technology Co.,Ltd · Oct 2022
SOMAVAC 100 Sustained Vacuum System
K222856 · Somavac Medical Solutions, Inc. · Oct 2022
Exsalta
K221676 · Drw Medical · Sep 2022