Cleared Traditional

MODIFIED BETATRON IV INSULIN INFUSION SYSTEM (K900498) - FDA 510(k) Clearance

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

K900498 · Cardiac Pacemakers, Inc. · General Hospital
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Feb 1990
Decision
36d
Days
Class 2
Risk

K900498 is an FDA 510(k) clearance for the MODIFIED BETATRON IV INSULIN INFUSION SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 23, 1990 after a review of 36 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 K900498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1990
Decision Date February 23, 1990
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZG Pump, Infusion, Insulin
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 - LZG Pump, Infusion, Insulin

All 83
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K900498.
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Extended Reservoir
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K211575 · Insulet Corporation · Aug 2021