Cleared Traditional

K110535 - ALARIS PC UNIT MODULE 8000 WITH SOFTWAR...

K110535 is an FDA 510(k) clearance for ALARIS PC UNIT MODULE 8000 WITH SOFTWAR..., manufactured by Carefusion 303, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K110535 · Carefusion 303, Inc. · General Hospital
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Mar 2012
Decision
395d
Days
Class 2
Risk

K110535 is an FDA 510(k) clearance for the ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on March 26, 2012 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Carefusion 303, Inc. devices

FDA 510(k) Submission Details - K110535

510(k) Number K110535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date March 26, 2012
Days to Decision 395 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
266d slower than avg
Panel avg: 129d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 460
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