Cleared Traditional

K200280 - MEDRAD Imaging Bulk Package Transfer Spike (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200280 · Bayer Medical Care, Inc. · General Hospital
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Jul 2020
Decision
177d
Days
Class 2
Risk

K200280 is an FDA 510(k) clearance for the MEDRAD Imaging Bulk Package Transfer Spike. Classified as Iodinated Contrast Media Transfer Tubing Set (product code PQH), Class II - Special Controls.

Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on July 30, 2020 after a review of 177 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 Bayer Medical Care, Inc. devices

Submission Details

510(k) Number K200280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2020
Decision Date July 30, 2020
Days to Decision 177 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
49d slower than avg
Panel avg: 128d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PQH Iodinated Contrast Media Transfer Tubing Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition The Iodinated Contrast Media Transfer Set Is Intended To Transfer Iodinated Contrast Media From Imaging Bulk Package Contrast Media In A Controlled Ambient Environment. The Transfer Set Is Intended To Be Used To Directly Fill Multiple Sterile Single Use Syringes From An Imaging Bulk Package Contrast Media Bulk Package Under Controlled Ambient Filling Conditions Such As A Ct Suite.
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.