Cleared Traditional

K833723 - MODEL 2000 AMBULATORY MED. INFUSER

K833723 is an FDA 510(k) clearance for MODEL 2000 AMBULATORY MED. INFUSER, 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 98-day FDA review.

K833723 · Parker Hannifin Corp. · General Hospital
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Jan 1984
Decision
98d
Days
Class 2
Risk

K833723 is an FDA 510(k) clearance for the MODEL 2000 AMBULATORY MED. INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Parker Hannifin Corp. (Walker, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 98 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 - K833723

510(k) Number K833723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1983
Decision Date January 30, 1984
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 K833723.
ETHOX RELIA-FLO 2001 ENTERAL FEED
K841512 · Ethox Corp. · May 1984
INFUSION PUMP
K832470 · Delta Medical Industries · Feb 1984
LIFECARE 4/HOMECARE - 4H PUMP
K840263 · Abbott Laboratories · Feb 1984
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983
FLO-GARD 8100 INFUSION PUMP
K833958 · Travenol Laboratories, S.A. · Dec 1983
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
K832285 · Travenol Laboratories, S.A. · Dec 1983