Cleared Special

K243138 - Geon (S2) Nasal Aspirator (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243138 · Geon Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
127d
Days
Class 2
Risk

K243138 is an FDA 510(k) clearance for the Geon (S2) Nasal Aspirator. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Geon Corporation (Chang Hwa Hsien, TW). The FDA issued a Cleared decision on February 4, 2025 after a review of 127 days - within the typical 510(k) review window.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Geon Corporation devices

Submission Details

510(k) Number K243138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date February 04, 2025
Days to Decision 127 days
Submission Type Special
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
38d slower than avg
Panel avg: 89d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

All 154
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K243138.
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
K253107 · Shenzhen Dongjiang Technology Co., Ltd. · Apr 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K260147 · Shenzhen Kingboom Technology Co., Ltd. · Mar 2026
Baby Nasal Aspirator (BN002)
K251450 · Shenzhen Desida Technology Co., Ltd. · Jun 2025
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
K244033 · Shenzhen Desida Technology Co., Ltd. · May 2025
AIRO Suction Unit (AIRO-01)
K251101 · Cro, LLC · Apr 2025
Electric Nasal Aspirator (BC026, BC025, BC023)
K250697 · Shenzhen Kingboom Technology Co., Ltd. · Apr 2025