Cleared Traditional

I.V. STAT MASTER (K852254) - FDA 510(k) Clearance

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

K852254 · The Master Medical Corp. · General Hospital
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Nov 1985
Decision
178d
Days
Class 2
Risk

K852254 is an FDA 510(k) clearance for the I.V. STAT MASTER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by The Master Medical Corp. (Chicago, US). The FDA issued a Cleared decision on November 18, 1985 after a review of 178 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 The Master Medical Corp. devices

Submission Details

510(k) Number K852254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1985
Decision Date November 18, 1985
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K852254.
SOLUTION ADMINISTRATION SET
K860541 · Travenol Laboratories, S.A. · Mar 1986
SOLUTION ADMINISTRATION SETS
K860272 · Travenol Laboratories, S.A. · Mar 1986
TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
K854446 · Terumo Medical Corp. · Jan 1986
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061 · Travenol Laboratories, S.A. · Mar 1985
ANTI-ASPIRATION VALVE
K843748 · Travenol Laboratories, S.A. · Jan 1985
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984