Cleared Traditional

K841187 - BLOOD COLLECTION SET, STERILE, DISPOS.

K841187 is an FDA 510(k) clearance for BLOOD COLLECTION SET, manufactured by Marbex, Inc.. The device is a Class 2 General Hospital device with product code BRZ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K841187 · Marbex, Inc. · General Hospital
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Jun 1984
Decision
94d
Days
Class 2
Risk

K841187 is an FDA 510(k) clearance for the BLOOD COLLECTION SET, STERILE, DISPOS.. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Marbex, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 94 days - within the typical 510(k) review window.

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 Marbex, Inc. devices

FDA 510(k) Submission Details - K841187

510(k) Number K841187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1984
Decision Date June 22, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BRZ Device Classification - Class 2, Special Controls

Product Code BRZ Set, Blood Transfusion
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.