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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K262822

510(k) cleared

Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)

Zhongshan GL Electronics Co. , Ltd. · Oct 7, 2026 · K262822

FDA cleared the Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) from Zhongshan GL Electronics Co. , Ltd. on Oct 7, 2026 under K262822, a traditional 510(k). The device falls under product code BTA, Pump, Portable, Aspiration (Manual Or Powered), regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 10, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zhongshan GL Electronics Co. , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262822?

K262822 is the FDA 510(k) for Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401), submitted by Zhongshan GL Electronics Co. , Ltd.. FDA's decision date was Oct 7, 2026, under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Who makes the Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)?

Zhongshan GL Electronics Co. , Ltd., based in Zhongshan, is the applicant of record for K262822.

How long did the K262822 review take?

FDA received the submission on Aug 10, 2026 and issued its decision on Oct 7, 2026, 58 days later.

← All decisions in October 2026