Cleared Traditional

K803183 - OFFENBACK REVERSIBLE BARIUM PUMP

K803183 is an FDA 510(k) clearance for OFFENBACK REVERSIBLE BARIUM PUMP, manufactured by The Offenback Co.. The device is a Class 2 Radiology device with product code FRN cleared through the Traditional 510(k) pathway after a 175-day FDA review.

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

FDA 510(k) Submission Details - K803183

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.

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 Radiology devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 619
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K803183.
AMP MARK IV INFUSION PUMP
K811918 · American Medical Products, Inc. · Jul 1981
ENTRI ENTERAL FEEDING PUMP
K811739 · Biosearch Medical Products, Inc. · Jul 1981
OPEN LOOP AMBULATORY INFUSION DEVICE
K811774 · Cardiac Pacemakers, Inc. · Jul 1981
MODEL 560 SERIES VOLUMETRIC INFUSION
K811238 · Y · Jun 1981
COMPUTER INTERFACE MODULE
K810295 · Y · Mar 1981
SIMPLICITY INFUSION PUMP MODEL 2100A
K803078 · Critikon Company, LLC · Jan 1981