Cleared Traditional

K952392 - MLI SET

K952392 is an FDA 510(k) clearance for MLI SET, manufactured by Medical Technologies of Georgia. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K952392 · Medical Technologies of Georgia · General Hospital
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Aug 1995
Decision
77d
Days
Class 2
Risk

K952392 is an FDA 510(k) clearance for the MLI SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medical Technologies of Georgia (Decatur, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Technologies of Georgia devices

FDA 510(k) Submission Details - K952392

510(k) Number K952392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1995
Decision Date August 07, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 709
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K952392.
PLASTIC BLUNT CANNULA
K952976 · Marquette Medical, Inc. · Sep 1995
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES
K950153 · Imed Corp. · Aug 1995
FIXED FLOW RATE GRAVITY ADMINISTRATION SETS
K952760 · I-Flow Corp. · Aug 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074 · Baxter Healthcare Corp · Jul 1995
ADMINISTRATION SETS WITH BALL FLOAT
K951922 · Imed Corp. · Jul 1995
FILTERED EXTENSION SETS
K942988 · B. Braun of America, Inc. · Jul 1995