Cleared Traditional

K863532 - MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER

K863532 is an FDA 510(k) clearance for MODIFIED LABELING TO MODEL 2000 AMBULAT..., manufactured by Parker Hannifin Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K863532 · Parker Hannifin Corp. · General Hospital
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Jan 1987
Decision
127d
Days
Class 2
Risk

K863532 is an FDA 510(k) clearance for the MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER. 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 January 14, 1987 after a review of 127 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K863532

510(k) Number K863532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date January 14, 1987
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 583
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K863532.
AMBULATORY INFUSION PUMP, MODEL AS30C
K863864 · Travenol Laboratories, S.A. · Feb 1987
STRATO(R) PCA INFUSER
K864808 · Strato Medical Corp. · Jan 1987
PERCUPUMP (TM)
K864227 · E-Z-Em, Inc. · Jan 1987
BARD HARVARD MINI-INFUSER 950 PUMP
K864233 · C.R. Bard, Inc. · Jan 1987
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
K864138 · Medtronic Minimed · Dec 1986
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · Abbott Laboratories · Dec 1986