Cleared Traditional

K262822 - Nasal Aspirator (TLC-N02)

Also marketed or referenced as:
Electric NoseFrida Pro (12300400) Electric NoseFrida (12100401)

K262822 is an FDA 510(k) clearance for Nasal Aspirator (TLC-N02), manufactured by Zhongshan GL Electronics Co. , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code BTA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K262822 · Zhongshan GL Electronics Co. , Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
58d
Days
Class 2
Risk

K262822 is an FDA 510(k) clearance for the Nasal Aspirator (TLC-N02). Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Zhongshan GL Electronics Co. , Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on October 7, 2026 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262822

510(k) Number K262822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2026
Decision Date October 07, 2026
Days to Decision 58 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
32d faster than avg
Panel avg: 90d · This submission: 58d
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 Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 159
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K262822.
Momcozy Nasal Aspirator (BN007)
K253629 · Shenzhen Root Innovation Technology Co., Ltd. · May 2026
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02
K260134 · Shenzhen Root Innovation Technology Co., Ltd. · May 2026
Suction Pump (SU-90)
K260892 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · May 2026
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
K260473 · Shenzhen Kingboom Technology Co., Ltd. · May 2026
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
K262822 · Nasal Aspirator (TLC-N02)
Download PDF FDA Summary Zhongshan GL Electron…