Cleared Traditional

K897086 - PARKER AMBULATORY MEDICATION INFUSION P...

K897086 is the FDA 510(k) clearance for PARKER AMBULATORY MEDICATION INFUSION P... by Parker Hannifin Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K897086 · Parker Hannifin Corp. · General Hospital
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Sep 1990
Decision
282d
Days
Class 2
Risk

K897086 is an FDA 510(k) clearance for the PARKER AMBULATORY MEDICATION INFUSION PUMP 2004. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Parker Hannifin Corp. (Irvine, US). The FDA issued a Cleared decision on September 28, 1990 after a review of 282 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 Parker Hannifin Corp. devices

Submission Details

510(k) Number K897086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date September 28, 1990
Days to Decision 282 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
153d slower than avg
Panel avg: 129d · This submission: 282d
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 427
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K897086.
IVAC(R) SYRINGE PUMP - MODEL 770
K901550 · Y · Oct 1990
IVAC(R) SYRINGE PUMP - MODEL 740
K903879 · Y · Oct 1990
MULTI DRUG INFUSION SYSTEM
K904048 · I-Flow Corp. · Oct 1990
MULTI-DRUG INFUSION SYSTEM
K901978 · I-Flow Corp. · Sep 1990
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · Abbott Laboratories · Sep 1990
CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
K902374 · Pharmacia Deltec, Inc. · Sep 1990