Cleared Traditional

K011729 - SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

K011729 is an FDA 510(k) clearance for SIGMA PACE EXTERNAL PACEMAKER ANALYZER ..., manufactured by Dni Nevada, Inc.. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K011729 · Dni Nevada, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
87d
Days
Class 2
Risk

K011729 is an FDA 510(k) clearance for the SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Dni Nevada, Inc. (Carson City, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 87 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 Dni Nevada, Inc. devices

FDA 510(k) Submission Details - K011729

510(k) Number K011729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date August 30, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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 26
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K011729.
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EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
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EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
K903966 · Bio-Tek Instruments, Inc. · Jun 1991
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595 · Medtronic Vascular · May 1991