Momcozy Nasal Aspirator (BN007)— 510(k) K253629

Clearance details

Applicant

Shenzhen Root Innovation Technology Co., Ltd.

Product code

Code BTA

Device class

Class 2

Regulation

21 CFR 878.4780

Advisory panel

General, Plastic Surgery

Date received

2025-11-19

Decision date

2026-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more2026-05-15
• K260892 — Suction Pump (SU-90)2026-05-14
• K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)2026-05-12
• K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)2026-04-14
• K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)2026-03-13

• K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)2026-06-18
• K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )2026-06-17
• K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)2026-04-29
• K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)2026-04-08
• K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)2026-04-07

Death

5

Total

5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →