510(k) K260845

Huahong Sharps Container (HHR-I, HHR-II) by Tianjin Huahong Technology Co., Ltd. — Product Code MMK

K260845 is an FDA 510(k) premarket notification submitted by Tianjin Huahong Technology Co., Ltd. for the device "Huahong Sharps Container (HHR-I, HHR-II)". The FDA issued a decision of Substantially Equivalent on August 5, 2026. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Tianjin Huahong Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2026
Date Received
March 16, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type