Cleared Special

K200661 - Steripath Micro Blood Collection System

K200661 is an FDA 510(k) clearance for Steripath Micro Blood Collection System, manufactured by Magnolia Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 210-day FDA review.

K200661 · Magnolia Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
210d
Days
Class 2
Risk

K200661 is an FDA 510(k) clearance for the Steripath Micro Blood Collection System. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Magnolia Medical Technologies, Inc. (Seattle, US). The FDA issued a Cleared decision on October 8, 2020 after a review of 210 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K200661

510(k) Number K200661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2020
Decision Date October 08, 2020
Days to Decision 210 days
Submission Type Special
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
81d slower than avg
Panel avg: 129d · This submission: 210d
Pathway characteristics
Modification to existing cleared device.

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 1171
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K200661 · Steripath Micro Blood Collection System
Download PDF FDA Summary Magnolia Medical Tech…