Cleared Traditional

K872774 - BETATRON IV SYSTEM

K872774 is the FDA 510(k) clearance for BETATRON IV SYSTEM by Cardiac Pacemakers, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K872774 · Cardiac Pacemakers, Inc. · General Hospital
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Jan 1988
Decision
175d
Days
Class 2
Risk

K872774 is an FDA 510(k) clearance for the BETATRON IV SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 175 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K872774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date January 05, 1988
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 129d · 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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 390
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K872774.
MODEL 3000 INFUSION PUMP
K871881 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
AUTO SYRINGE MODEL AS20G INFUSION PUMP
K873746 · Baxter Healthcare Corp · Jan 1988
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
K873884 · Y · Jan 1988
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K873522 · C.R. Bard, Inc. · Dec 1987
BARD MICROINFUSER I INSULIN INFUSION PUMP
K871807 · C.R. Bard, Inc. · Dec 1987
IVAC(R) DUAL RATE SET - MODEL C50066
K873938 · Y · Dec 1987