Cleared Traditional

K910595 - MODEL 5311B A-V PACING SYSTEM ANALYZER

K910595 is an FDA 510(k) clearance for MODEL 5311B A-V PACING SYSTEM ANALYZER, 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 84-day FDA review.

K910595 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K910595

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.

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 K910595.
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · Pace Medical · Oct 2000
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K961582 · North American Technical Services Corp. · Nov 1996
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
K903966 · Bio-Tek Instruments, Inc. · Jun 1991
CPI MODEL 2215/SEAMED MODEL 3400
K910223 · Seamed Corp. · Mar 1991
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
K901332 · Biotronik, GmbH & Co. · May 1990
MEDTRONIC MODEL 5401B TEST CABLE
K896632 · Medtronic Vascular · Dec 1989