Cleared Traditional

K080297 - MEDRAD INTEGO PET INFUSION SYSTEM

K080297 is an FDA 510(k) clearance for MEDRAD INTEGO PET INFUSION SYSTEM, manufactured by Medrad, Inc.. The device is a Class 2 Radiology device with product code FRN cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K080297 · Medrad, Inc. · Radiology device
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Jun 2008
Decision
134d
Days
Class 2
Risk

K080297 is an FDA 510(k) clearance for the MEDRAD INTEGO PET INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on June 17, 2008 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.5725 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

FDA 510(k) Submission Details - K080297

510(k) Number K080297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2008
Decision Date June 17, 2008
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
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 Radiology devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 601
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