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FDA 510(k)

Suction Pump (SU-90)

K-Number: K260892 · 2026-05-14

ApplicantShenzhen HugeMed Medical Technical Development Co., Ltd.
Decision Date2026-05-14
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Suction Pump (SU-90) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260892. 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 Suction Pump (SU-90)?

Suction Pump (SU-90) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K260892.

When did Suction Pump (SU-90) receive FDA 510(k) clearance?

Suction Pump (SU-90) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260892.

Who is the listed applicant for Suction Pump (SU-90)?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Suction Pump (SU-90)?

The FDA product code for Suction Pump (SU-90) is BTA.

Other records listing Shenzhen HugeMed Medical Technical Development Co., Ltd. as applicant

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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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.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.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.

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