Cleared Traditional

K933524 - EXTENTION SET

K933524 is an FDA 510(k) clearance for EXTENTION SET, manufactured by Mediziv Medical Products 1987 , Ltd.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 672-day FDA review.

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

FDA 510(k) Submission Details - K933524

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.

FPK Device Classification - Class 2, Special Controls

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

All 31
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K933524.
SILCLEAR TUBING (MODIFICATION)
K953864 · Degania Silicone , Ltd. · Nov 1995
SYSMEX SF-3000
K950508 · Sysmex Corp. · Nov 1995
RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995
SILCLEAR TUBING
K943992 · Degania Silicone , Ltd. · Mar 1995
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · Visitec Co. · Nov 1992
LO-PROFILE EXTENSION SET
K915560 · Douglas Medical Products Corp. · May 1992