Cleared Traditional

K150921 - Orbit Infusion Set

K150921 is an FDA 510(k) clearance for Orbit Infusion Set, manufactured by Ypsomed AG. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 372-day FDA review.

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

FDA 510(k) Submission Details - K150921

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.

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 534
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K150921.
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K161323 · Baxter Healthcare Corporation · Nov 2016
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K153440 · C.R. Bard, Inc. · Aug 2016
Hospira Administration Sets
K160870 · Hospira, Inc. · Jun 2016
BD FlowSmart Set, MiniMed Pro-Set
K160651 · Becton, Dickinson and Company · Apr 2016
Extension Set
K153293 · B.Braun Medical, Inc. · Apr 2016
Hospira Extension Sets
K151969 · Icu Medical, Inc. · Jan 2016