Cleared Traditional

K823204 - BETATRON II

K823204 is the FDA 510(k) clearance for BETATRON II by Cardiac Pacemakers, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K823204 · Cardiac Pacemakers, Inc. · General Hospital
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Nov 1982
Decision
34d
Days
Class 2
Risk

K823204 is an FDA 510(k) clearance for the BETATRON II. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1982 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K823204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1982
Decision Date November 30, 1982
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 393
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K823204.
HARVARD APPARATUS FAMILY OF FLUID INFUS
K830177 · C.R. Bard, Inc. · Feb 1983
VOLUMETRIC PUMP ADMIN. SETS
K830017 · Travenol Laboratories, S.A. · Jan 1983
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB
K823063 · Travenol Laboratories, S.A. · Nov 1982
COMPUTER INTERFACE MODULE CIM
K823035 · Y · Nov 1982
HARVARD APPARATUS SINGLE SPEED SYRINGE
K822989 · C.R. Bard, Inc. · Nov 1982
FLEXIFLO-II
K821661 · Abbott Laboratories · Jun 1982