Cleared Traditional

K051264 - COMFORT AND INSET SUBCUTANEOUS INFUSION...

K051264 is an FDA 510(k) clearance for COMFORT AND INSET SUBCUTANEOUS INFUSION..., 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 108-day FDA review.

K051264 · Unomedical A/S · General Hospital
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Sep 2005
Decision
108d
Days
Class 2
Risk

K051264 is an FDA 510(k) clearance for the COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Unomedical A/S (Roskilde, DK). The FDA issued a Cleared decision on September 1, 2005 after a review of 108 days - within the typical 510(k) review window.

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 Unomedical A/S devices

FDA 510(k) Submission Details - K051264

510(k) Number K051264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date September 01, 2005
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
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 K051264.
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CONTRAST MEDIA TRANSFER SETS
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K050207 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2005