Cleared Traditional

K860322 - CLINISET INFUSION SET

K860322 is an FDA 510(k) clearance for CLINISET INFUSION SET, manufactured by Zimmar Consulting , Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K860322 · Zimmar Consulting , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
68d
Days
Class 2
Risk

K860322 is an FDA 510(k) clearance for the CLINISET INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Zimmar Consulting , Ltd. (Montreal, Canada H3a2n4, CA). The FDA issued a Cleared decision on April 7, 1986 after a review of 68 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 Zimmar Consulting , Ltd. devices

FDA 510(k) Submission Details - K860322

510(k) Number K860322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1986
Decision Date April 07, 1986
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 129d · This submission: 68d
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 644
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K860322.
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
SOLUTION ADMINISTRATION SET
K860541 · Travenol Laboratories, S.A. · Mar 1986
SOLUTION ADMINISTRATION SETS
K860272 · Travenol Laboratories, S.A. · Mar 1986
CHURCHILL - HBC VENTED BALL CHECK IV SET
K854658 · Churchill Corp. · Jan 1986