Cleared Traditional

K192247 - Steripath Gen2 Blood Collection System

K192247 is the FDA 510(k) clearance for Steripath Gen2 Blood Collection System by Magnolia Medical Technologies, Inc.. It is a Class 2 General Hospital device (product code JKA) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K192247 · Magnolia Medical Technologies, Inc. · General Hospital
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Feb 2020
Decision
193d
Days
Class 2
Risk

K192247 is an FDA 510(k) clearance for the Steripath Gen2 Blood Collection System. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Magnolia Medical Technologies, Inc. (Seattle, US). The FDA issued a Cleared decision on February 28, 2020 after a review of 193 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - 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 Magnolia Medical Technologies, Inc. devices

Submission Details

510(k) Number K192247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2019
Decision Date February 28, 2020
Days to Decision 193 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
64d slower than avg
Panel avg: 129d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 115
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