Decision Date2026-05-26
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Momcozy Nasal Aspirator (BN007) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K253629. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Momcozy Nasal Aspirator (BN007)?
Momcozy Nasal Aspirator (BN007) is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K253629.
When did Momcozy Nasal Aspirator (BN007) receive FDA 510(k) clearance?
Momcozy Nasal Aspirator (BN007) received FDA 510(k) clearance on 2026-05-26, under 510(k) number K253629.
Who is the listed applicant for Momcozy Nasal Aspirator (BN007)?
The FDA 510(k) record lists Shenzhen Root Innovation Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Momcozy Nasal Aspirator (BN007)?
The FDA product code for Momcozy Nasal Aspirator (BN007) is BTA.
Other records listing Shenzhen Root Innovation Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)K254258Momcozy 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)K253946Momcozy 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) View all 13 devices →
Related Devices (Code: BTA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)Shenzhen Desida Technology Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.