Cleared Traditional

nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

K251257 · Np Medical · General Hospital

Dec 2025

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K251257 is an FDA 510(k) clearance for the nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727], a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Np Medical (Clinton, US). The FDA issued a Cleared decision on December 4, 2025, 225 days after receiving the submission on April 23, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K251257 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2025
Decision Date	December 04, 2025
Days to Decision	225 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF