FDA cleared the Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) from Shenzhen Root Innovation Technology Co., Ltd. on May 15, 2026 under K260134, 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 Jan 16, 2026. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Shenzhen Root Innovation Technology Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K254254 (Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)), K260538 (Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )), K253629 (Momcozy Nasal Aspirator (BN007)), K253914 (Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)).