Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more— 510(k) K260134
Substantially EquivalentShenzhen Root Innovation Technology Co., Ltd.
FDA 510(k) clearance K260134 for Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more, Substantially Equivalent on 2026-05-15. Applicant: Shenzhen Root Innovation Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Root Innovation Technology's Baby Nasal Aspirator is listed with 12 model numbers: BN006 and BN008, each with -A through -D variants, plus BN02 and BC-021. It's filed under BTA, manual or powered portable aspiration pumps.
Class II, 21 CFR 878.4780. The Ear, Nose, Throat review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
The company filed from Shenzhen, China. The decision came 119 calendar days after receipt (January 16 to May 15, 2026).
Clearance details
- Device name as filed
- Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
- Applicant
- Shenzhen Root Innovation Technology 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
- Shenzhen, CN
Recent devices under product code BTA
view all- K262822 — Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)
- K253629 — Momcozy Nasal Aspirator (BN007)
- 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)
More clearances from Shenzhen Root Innovation Technology Co., Ltd.
view all- 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 )
- K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
- 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)
- 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)
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.