Cleared Traditional

K143087 - Hospira Blood Set

K143087 is an FDA 510(k) clearance for Hospira Blood Set, manufactured by Hospira, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K143087 · Hospira, Inc. · General Hospital
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Mar 2015
Decision
128d
Days
Class 2
Risk

K143087 is an FDA 510(k) clearance for the Hospira Blood Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 4, 2015 after a review of 128 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 Hospira, Inc. devices

FDA 510(k) Submission Details - K143087

510(k) Number K143087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2014
Decision Date March 04, 2015
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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 Consultant

Icu Medical, Inc.
Jeannette Marinoni

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 726
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K143087.
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K151079 · Quest Medical, Inc. · Sep 2015
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K150860 · Baxter Healthcare Corporation · Apr 2015
Hospira Primary Sets
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All Safe Huber Safety Infusion Set
K142590 · Nexus Medical, LLC · Jan 2015
IV Administration
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