Cleared Traditional

K000592 - UNOLOK PLUS INFUSION SET AND VAKU-8 PLU...

K000592 is an FDA 510(k) clearance for UNOLOK PLUS INFUSION SET AND VAKU-8 PLU..., manufactured by Myco Medical Supplies, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 415-day FDA review.

K000592 · Myco Medical Supplies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
415d
Days
Class 2
Risk

K000592 is an FDA 510(k) clearance for the UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on April 12, 2001 after a review of 415 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 Myco Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K000592

510(k) Number K000592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date April 12, 2001
Days to Decision 415 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
286d slower than avg
Panel avg: 129d · This submission: 415d
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 533
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K000592.
SIMPLICITY SOFT QD EASY INFUSION SET
K010788 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY WINGED QD INFUSION SET
K010676 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY INFUSER INFUSION SET
K010647 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY SILVER SET SOFT INFUSION
K010846 · Sterling Medivations, Inc. · Apr 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
K010373 · Sterling Medivations, Inc. · Mar 2001