Cleared Traditional

K850077 - MEDTRONIC 5311 PACING SYSTEM ANALYZER (FDA 510(k) Clearance)

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

K850077 · Medtronic Vascular · Cardiovascular device
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Jul 1985
Decision
188d
Days
Class 2
Risk

K850077 is an FDA 510(k) clearance for the MEDTRONIC 5311 PACING SYSTEM ANALYZER. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 16, 1985 after a review of 188 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K850077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1985
Decision Date July 16, 1985
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
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.