Cleared Traditional

PARTNER INFUSION SYSTEM: (K896717) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896717 · Q-Life Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
246d
Days
Class 2
Risk

K896717 is an FDA 510(k) clearance for the PARTNER INFUSION SYSTEM:. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Q-Life Systems, Inc. (Kingston, Ontario, CA). The FDA issued a Cleared decision on August 2, 1990 after a review of 246 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Q-Life Systems, Inc. devices

Submission Details

510(k) Number K896717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1989
Decision Date August 02, 1990
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K896717.
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · Abbott Laboratories · Sep 1990
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · Abbott Laboratories · Aug 1990
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
K900375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K902409 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · Abbott Laboratories · Jul 1990