Cleared Traditional

K132142 - NERIA SOFT 90 INFUSION SET (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132142 · Unomedical A/S · General Hospital

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Oct 2013

Decision

89d

Days

Class 2

Risk

K132142 is an FDA 510(k) clearance for the NERIA SOFT 90 INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Unomedical A/S (Rotherham, Sout Yorkshire, GB). The FDA issued a Cleared decision on October 8, 2013 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Unomedical A/S devices

Submission Details

510(k) Number	K132142 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 11, 2013
Decision Date	October 08, 2013
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

39d faster than avg

Panel avg: 128d · This submission: 89d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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.