Cleared Traditional

K860616 - VOLUME CONTROL SET WITH EXTENSION

K860616 is the FDA 510(k) clearance for VOLUME CONTROL SET WITH EXTENSION by Med Fusion Systems, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K860616 · Med Fusion Systems, Inc. · General Hospital
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Jun 1986
Decision
103d
Days
Class 2
Risk

K860616 is an FDA 510(k) clearance for the VOLUME CONTROL SET WITH EXTENSION. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Med Fusion Systems, Inc. (Norcross, US). The FDA issued a Cleared decision on June 2, 1986 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Med Fusion Systems, Inc. devices

Submission Details

510(k) Number K860616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date June 02, 1986
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 471
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K860616.
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164 · Y · Dec 1986
SECONDARY SET LOCK
K864338 · Travenol Laboratories, S.A. · Nov 1986
LUER LOCK ADAPTER/NUT
K862653 · Mallinckrodt Critical Care · Jul 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