Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)— 510(k) K262822
Substantially EquivalentZhongshan GL Electronics Co. , Ltd.
FDA 510(k) clearance K262822 for Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401), Substantially Equivalent on 2026-10-07. Applicant: Zhongshan GL Electronics Co. , Ltd.. Device class: 2.
Summary
Three nasal aspirators are covered by this clearance: the Nasal Aspirator (TLC-N02), the Electric NoseFrida Pro (12300400), and the Electric NoseFrida (12100401). Product code BTA is portable aspiration pumps, manual or powered.
Class II, 21 CFR 878.4780. The Ear, Nose, and Throat review panel handled it as a Traditional 510(k); the record lists General and Plastic Surgery as the classification panel.
Zhongshan GL Electronics filed from Zhongshan, China. Review took 58 days (August 10 to October 7, 2026).
Clearance details
- Applicant
- Zhongshan GL Electronics Co. , Ltd.
- Product code
- Product code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhongshan, CN
Recent devices under product code BTA
view all- K253629 — Momcozy Nasal Aspirator (BN007)
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K260892 — Suction Pump (SU-90)
- K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
- K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.