Cleared Traditional

K151969 - Hospira Extension Sets

K151969 is the FDA 510(k) clearance for Hospira Extension Sets by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K151969 · Icu Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2016
Decision
187d
Days
Class 2
Risk

K151969 is an FDA 510(k) clearance for the Hospira Extension Sets. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on January 19, 2016 after a review of 187 days - an extended review 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: 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K151969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date January 19, 2016
Days to Decision 187 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
58d slower than avg
Panel avg: 129d · This submission: 187d
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

Hospira, Inc.
Charles Neitzel

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 372
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K151969.
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
Solution Administration Sets with 0.2 Micron Filter
K153158 · Baxter Healthcare Corporation · Dec 2015
BD FlowSmart Set, MiniMed Pro-Set
K153257 · Becton, Dickinson and Company · Dec 2015
IV Administration Sets with 200(micro)m Blood Filter
K143082 · B.Braun Medical, Inc. · Jul 2015