Suction Pump (SU-90)— 510(k) K260892
Substantially EquivalentShenzhen HugeMed Medical Technical Development Co., Ltd.
FDA 510(k) clearance K260892 for Suction Pump (SU-90), Substantially Equivalent on 2026-05-14. Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Device class: 2.
Summary
Shenzhen HugeMed Medical Technical Development's Suction Pump (SU-90) is filed under BTA, manual or powered portable aspiration pumps. Apart from the model number, the name is generic.
Class II, 21 CFR 878.4780. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
HugeMed filed from Shenzhen, China. Review took 57 calendar days (March 18 to May 14, 2026).
Clearance details
- Applicant
- Shenzhen HugeMed Medical Technical Development 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
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More clearances from Shenzhen HugeMed Medical Technical Development Co., Ltd.
view allAdverse 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.