510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212019Substantially Equivalent

Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single

Jiangsu Micsafe Medical Technology Co., Ltd, Yancheng, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212019 is the FDA 510(k) clearance record for Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single, a class II device, cleared for Jiangsu Micsafe Medical Technology Co., Ltd. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 5 510(k) clearances for Jiangsu Micsafe Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K212019.

Clearance record

Decision date
Received
(129 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Jiangsu Micsafe Medical Technology Co., Ltd. Xituan Industrial Park, Dafeng District, Yancheng, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JKA

Trailing 12 months
6 clearances under product code JKA in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260