Cleared Traditional

K850077 - MEDTRONIC 5311 PACING SYSTEM ANALYZER

K850077 is an FDA 510(k) clearance for MEDTRONIC 5311 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 188-day FDA review.

K850077 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K850077

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
Combination Product No
PCCP Authorized No
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.

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 K850077.
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
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · Cordis Corp. · May 1985
TELECTRONICS MODEL 2401
K831697 · Seamed Corp. · Sep 1984
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · Medtronic Vascular · Jun 1982