Cleared Traditional

K884331 - MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER

K884331 is an FDA 510(k) clearance for MEDTRONIC MODEL 5311B A-V PACING SYSTEM..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K884331 · Medtronic Vascular · Cardiovascular device
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Jan 1989
Decision
88d
Days
Class 2
Risk

K884331 is an FDA 510(k) clearance for the MEDTRONIC 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 January 10, 1989 after a review of 88 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

FDA 510(k) Submission Details - K884331

510(k) Number K884331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date January 10, 1989
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTC Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K884331.
CPI MODEL 2215/SEAMED MODEL 3400
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PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
K901332 · Biotronik, GmbH & Co. · May 1990
MEDTRONIC MODEL 5401B TEST CABLE
K896632 · Medtronic Vascular · Dec 1989
PACER SENSING ANALYZER (PSA 100)
K882327 · Oscor Medical Corp. · Oct 1988
SEAMED MODEL 3000
K860462 · Seamed Corp. · Aug 1986
SEA MED DDD PACING SYSTEM ANALYZER
K851900 · Seamed Corp. · Jul 1985