Cleared Traditional

MiniMed Mio Advance infusion set (K173879) - FDA 510(k) Clearance

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

K173879 · Unomedical A/S · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
74d
Days
Class 2
Risk

K173879 is an FDA 510(k) clearance for the MiniMed Mio Advance 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 March 5, 2018 after a review of 74 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 K173879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date March 05, 2018
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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.

Regulatory Consultant

Emergo Global Consulting, LLC
Deirdre Barrow

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPA Set, Administration, Intravascular

All 237
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K173879.
BD FlowSmart Set/MiniMed Pro-Set
K181718 · Becton, Dickinson and Company · Oct 2018
AMSafe Sure-Lok Needle-Free Connector
K173665 · Amsino International, Inc. · Sep 2018
IV Administration Set
K173361 · B.Braun Medical, Inc. · Jun 2018
IV Administration Sets
K170595 · B.Braun Medical, Inc. · Nov 2017
Medline Blood Collection Set
K170002 · Medline Industries, Inc. · Sep 2017
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
K153440 · C.R. Bard, Inc. · Aug 2016