510(k) K252899

Female Culture Device; Male Culture Device; Transfer Device; Access Device by Zhejiang Kindly Medical Device Co., Ltd. — Product Code JKA

K252899 is an FDA 510(k) premarket notification submitted by Zhejiang Kindly Medical Device Co., Ltd. for the device "Female Culture Device; Male Culture Device; Transfer Device; Access Device". The FDA issued a decision of Substantially Equivalent on June 2, 2026. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Zhejiang Kindly Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2026
Date Received
September 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type