Cleared Traditional

K833306 - BETATRON I AMBULATORY INSULIN PUMP

K833306 is an FDA 510(k) clearance for BETATRON I AMBULATORY INSULIN PUMP, manufactured by Cardiac Pacemakers, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K833306 · Cardiac Pacemakers, Inc. · General Hospital
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Nov 1983
Decision
66d
Days
Class 2
Risk

K833306 is an FDA 510(k) clearance for the BETATRON I AMBULATORY INSULIN PUMP. 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 28, 1983 after a review of 66 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.

FDA 510(k) Submission Details - K833306

510(k) Number K833306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1983
Decision Date November 28, 1983
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 803
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K833306.
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K832923 · Caridac Pacemakers, Inc. · Nov 1983
WINDSOR MEDICAL MODEL 52
K832641 · Windsor Medical, Inc. · Oct 1983
K833306 · BETATRON I AMBULATORY INSULIN PUMP
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