Cleared Traditional

K141285 - BUSSE EXTENSION SET

K141285 is an FDA 510(k) clearance for BUSSE EXTENSION SET, manufactured by Busse Hospital Disposables. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K141285 · Busse Hospital Disposables · General Hospital
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Feb 2015
Decision
279d
Days
Class 2
Risk

K141285 is an FDA 510(k) clearance for the BUSSE EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Busse Hospital Disposables (Hauppauge, US). The FDA issued a Cleared decision on February 19, 2015 after a review of 279 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 Busse Hospital Disposables devices

FDA 510(k) Submission Details - K141285

510(k) Number K141285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2014
Decision Date February 19, 2015
Days to Decision 279 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
150d slower than avg
Panel avg: 129d · This submission: 279d
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 572
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K141285.
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K150860 · Baxter Healthcare Corporation · Apr 2015
Hospira Blood Set
K143087 · Hospira, Inc. · Mar 2015
Hospira Primary Sets
K143015 · Hospira, Inc. · Feb 2015
IV Administration
K142622 · Hospira, Inc. · Jan 2015
Extension Sets
K142974 · Hospira, Inc. · Jan 2015
Hospira Extension Set
K142433 · Hospira, Inc. · Dec 2014