Cleared Traditional

K251257 - nSet+ Stabilization Set [6426733]

Also marketed or referenced as:
nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731] nSyte Needle Free Connector (NFC) [6426727]

K251257 is an FDA 510(k) clearance for nSet+ Stabilization Set [6426733], manufactured by Np Medical. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K251257 · Np Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
225d
Days
Class 2
Risk

K251257 is an FDA 510(k) clearance for the nSet+ Stabilization Set [6426733]. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Np Medical (Clinton, US). The FDA issued a Cleared decision on December 4, 2025 after a review of 225 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Np Medical devices

FDA 510(k) Submission Details - K251257

510(k) Number K251257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 129d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 532
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