Cleared Traditional

K852167 - ISOVOL-EXCHANGE TRAY

K852167 is an FDA 510(k) clearance for ISOVOL-EXCHANGE TRAY, manufactured by Rocky Mountain Medical Corp.. The device is a Class 2 General Hospital device with product code BRZ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K852167 · Rocky Mountain Medical Corp. · General Hospital
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Nov 1985
Decision
182d
Days
Class 2
Risk

K852167 is an FDA 510(k) clearance for the ISOVOL-EXCHANGE TRAY. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Rocky Mountain Medical Corp. (Greenwood Village, US). The FDA issued a Cleared decision on November 18, 1985 after a review of 182 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 Rocky Mountain Medical Corp. devices

FDA 510(k) Submission Details - K852167

510(k) Number K852167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date November 18, 1985
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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.