Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Co
Summary
Jiangsu Kangbao Medical Equipment Co., Ltd. received 510(k) clearance for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder, a JKA device. Cleared on 2023-12-22.
Details
Source
510(k) Clearance
External ID
K232881
Action Date
2023-12-22
Status
Traditional
Category
device
Product Code
JKA
Product Description
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder. Product code: JKA.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Jiangsu Kangbao Medical Equipment Co., Ltd. has received 3 total clearances in our database.
Jiangsu Kangbao Medical Equipment Co., Ltd. has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Jiangsu Kangbao Medical Equipment Co., Ltd. have FDA actions?
Jiangsu Kangbao Medical Equipment Co., Ltd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232881" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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