Cleared Traditional

K162812 - Unomedical Comfort Subcutaneous Infusio...

K162812 is an FDA 510(k) clearance for Unomedical Comfort Subcutaneous Infusio..., manufactured by Unomedical A/S. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K162812 · Unomedical A/S · General Hospital
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Nov 2017
Decision
391d
Days
Class 2
Risk

K162812 is an FDA 510(k) clearance for the Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcut.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Unomedical A/S (Osted, DK). The FDA issued a Cleared decision on November 1, 2017 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Unomedical A/S devices

FDA 510(k) Submission Details - K162812

510(k) Number K162812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2016
Decision Date November 01, 2017
Days to Decision 391 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
262d slower than avg
Panel avg: 129d · This submission: 391d
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 533
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K162812.
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K161808 · Baxter Healthcare Corporation · Jun 2017