Cleared Traditional

Orbit Infusion Set (K150921) - FDA 510(k) Clearance

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

K150921 · Ypsomed AG · General Hospital
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Apr 2016
Decision
372d
Days
Class 2
Risk

K150921 is an FDA 510(k) clearance for the Orbit Infusion Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on April 12, 2016 after a review of 372 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 Ypsomed AG devices

Submission Details

510(k) Number K150921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date April 12, 2016
Days to Decision 372 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
243d slower than avg
Panel avg: 129d · This submission: 372d
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 Peers - FPA Set, Administration, Intravascular

All 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K150921.
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K153293 · B.Braun Medical, Inc. · Apr 2016
BD FlowSmart Set, MiniMed Pro-Set
K153257 · Becton, Dickinson and Company · Dec 2015