Cleared Traditional

OFFENBACK REVERSIBLE BARIUM PUMP (K803183) - FDA 510(k) Clearance

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

K803183 · The Offenback Co. · Radiology device
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Jun 1981
Decision
175d
Days
Class 2
Risk

K803183 is an FDA 510(k) clearance for the OFFENBACK REVERSIBLE BARIUM PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by The Offenback Co. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.5725 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Offenback Co. devices

Submission Details

510(k) Number K803183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1980
Decision Date June 09, 1981
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 107d · This submission: 175d
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 Radiology devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K803183.
FLO-GARD 8000 INFUSION PUMP SYSTEM
K813403 · Travenol Laboratories, S.A. · Dec 1981
3M INFUSION SYSTEM
K812442 · 3M Company · Sep 1981
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · Terumo Medical Corp. · Sep 1981
TRAVENOL INFUSION PUMP-2M8016
K802901 · Travenol Laboratories, S.A. · Dec 1980
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)
K802820 · Travenol Laboratories, S.A. · Dec 1980
CORDIS DOW INFUSION PUMP
K802301 · Cordis Corp. · Oct 1980