Cleared Traditional

PACEMAKER SYS ANALYZER #384 (K833647) - FDA 510(k) Clearance

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

K833647 · Pacesetter Systems · Cardiovascular device
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Dec 1983
Decision
60d
Days
Class 2
Risk

K833647 is an FDA 510(k) clearance for the PACEMAKER SYS ANALYZER #384. Classified as Analyzer, Pacemaker Generator Function, Indirect (product code KRE), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3640 - the FDA cardiovascular device 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K833647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date December 16, 1983
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRE Analyzer, Pacemaker Generator Function, Indirect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3640
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 Cardiovascular devices follow this clearance model.