Cleared Traditional

MODEL 5311B A-V PACING SYSTEM ANALYZER (K910595) - FDA 510(k) Clearance

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

K910595 · Medtronic Vascular · Cardiovascular device
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May 1991
Decision
84d
Days
Class 2
Risk

K910595 is an FDA 510(k) clearance for the MODEL 5311B A-V 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 May 7, 1991 after a review of 84 days - a notably fast clearance 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: 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 Medtronic Vascular devices

Submission Details

510(k) Number K910595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date May 07, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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.

Regulatory Peers - DTC Analyzer, Pacemaker Generator Function

All 7
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K910595.
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K896632 · Medtronic Vascular · Dec 1989
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331 · Medtronic Vascular · Jan 1989
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077 · Medtronic Vascular · Jul 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · Cordis Corp. · May 1985
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · Medtronic Vascular · Jun 1982