Cleared Traditional

K861520 - UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)

K861520 is an FDA 510(k) clearance for UNIVERSAL DISPOSABLE INFUSION SET (CODE..., manufactured by Jufrey Multimed Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K861520 · Jufrey Multimed Corp. · General Hospital
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May 1986
Decision
34d
Days
Class 2
Risk

K861520 is an FDA 510(k) clearance for the UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Jufrey Multimed Corp. (Washington, US). The FDA issued a Cleared decision on May 27, 1986 after a review of 34 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 Jufrey Multimed Corp. devices

FDA 510(k) Submission Details - K861520

510(k) Number K861520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1986
Decision Date May 27, 1986
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 645
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K861520.
TIMELINE VENIPUNCTURE SYSTEM
K860609 · Ipax, Inc. · Jun 1986
TIMELINE VENIPUNCTURE SYSTEM
K861182 · Ipax, Inc. · Jun 1986
VOLUME CONTROL SET WITH EXTENSION
K860616 · Med Fusion Systems, Inc. · Jun 1986
CHURCHILL INJECTION SITE
K861430 · Churchill Corp. · May 1986
CHURCHILL FEMALE LUER LOCK CAP
K861439 · Churchill Corp. · May 1986
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
K860157 · Quest Medical, Inc. · Apr 1986