← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection

DEVICE CLASS
Class II
REGULATION
21 CFR 862.1675
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K252899Zhejiang Kindly Medical Device Co., Ltd. · 510k2026-06-02
K260128Becton, Dickinson and Company · 510k2026-04-15
K252506Becton, Dickinson and Company · 510k2026-04-10
K252378Becton, Dickinson and Company · 510k2026-04-10
K252040Becton, Dickinson and Company · 510k2026-03-13
K251812Magnolia Medical Technologies · 510k2025-09-25
K243207Becton, Dickinson and Company · 510k2025-07-03
K250961Promisemed Hangzhou Meditech Co., Ltd. · 510k2025-06-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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