Cleared Traditional

ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP (K850792) - FDA 510(k) Clearance

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

K850792 · Janssen Pharmaceutica, Inc. · General Hospital
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Nov 1985
Decision
260d
Days
Class 2
Risk

K850792 is an FDA 510(k) clearance for the ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Janssen Pharmaceutica, Inc. (Piscataway, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 260 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 Janssen Pharmaceutica, Inc. devices

Submission Details

510(k) Number K850792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date November 13, 1985
Days to Decision 260 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
131d slower than avg
Panel avg: 129d · This submission: 260d
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 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K850792.
MODEL 900 INFUSION PUMP
K860229 · C.R. Bard, Inc. · Apr 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · C.R. Bard, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · Travenol Laboratories, S.A. · Nov 1985
SYRINGE INFUSION PUMP - AS 20 SERIES
K852358 · Baxter Healthcare Corp · Jul 1985
MODEL 2000 INDULIN INFUSION PUMP
K851564 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1985