Cleared Traditional

K210544 - Medtronic Extended infusion set

K210544 is an FDA 510(k) clearance for Medtronic Extended infusion set, manufactured by Unomedical A/S. The device is a Class 2 Chemistry device with product code FPA cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K210544 · Unomedical A/S · Chemistry device
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Jul 2021
Decision
142d
Days
Class 2
Risk

K210544 is an FDA 510(k) clearance for the Medtronic Extended infusion set. 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 July 16, 2021 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5440 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Unomedical A/S devices

FDA 510(k) Submission Details - K210544

510(k) Number K210544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2021
Decision Date July 16, 2021
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 88d · This submission: 142d
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 Chemistry devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K210544.
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