Cleared Traditional

EXTENTION SET (K933524) - FDA 510(k) Clearance

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

K933524 · Mediziv Medical Products 1987 , Ltd. · General Hospital
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May 1995
Decision
672d
Days
Class 2
Risk

K933524 is an FDA 510(k) clearance for the EXTENTION SET. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Mediziv Medical Products 1987 , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 23, 1995 after a review of 672 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Mediziv Medical Products 1987 , Ltd. devices

Submission Details

510(k) Number K933524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1993
Decision Date May 23, 1995
Days to Decision 672 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
543d slower than avg
Panel avg: 129d · This submission: 672d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPK Tubing, Fluid Delivery
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 - FPK Tubing, Fluid Delivery

Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K933524.
LIFESHIELD EXTENSION SET
K912103 · Abbott Laboratories · Dec 1991
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · 3M Company · May 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · 3M Company · May 1989
MERIT HI-FLEX(TM)
K883718 · Merit Medical Systems, Inc. · Jan 1989
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981