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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 a medical device manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under approval 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. It is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K260892.

When was Suction Pump (SU-90) approved by the FDA?

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

What company makes Suction Pump (SU-90)?

Suction Pump (SU-90) is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd..

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

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

Related Devices (Code: BTA)

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.

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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