SURFLO Hybria Closed System Safety IV Catheter
Summary
Terumo Medical Products (Hangzhou) Co., Ltd. received 510(k) clearance for SURFLO Hybria Closed System Safety IV Catheter, a FOZ device. Cleared on 2025-12-17.
Details
Source
510(k) Clearance
External ID
K252398
Action Date
2025-12-17
Status
Traditional
Category
device
Product Code
FOZ
Product Description
SURFLO Hybria Closed System Safety IV Catheter. Product code: FOZ.
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. Terumo Medical Products (Hangzhou) Co., Ltd. has received 4 total clearances in our database.
Terumo Medical Products (Hangzhou) Co., Ltd. has 4 FDA actions in our database, including 4 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 Terumo Medical Products (Hangzhou) Co., Ltd. have FDA actions?
Terumo Medical Products (Hangzhou) Co., Ltd. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252398" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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