Cleared Traditional

EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR (K991293) - FDA 510(k) Clearance

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

K991293 · Fischer Medical Technologies, Inc. · Cardiovascular device
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May 2000
Decision
386d
Days
Class 2
Risk

K991293 is an FDA 510(k) clearance for the EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHY.... Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Fischer Medical Technologies, Inc. (Denver, US). The FDA issued a Cleared decision on May 5, 2000 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1750 - 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. Elevated predicate reliance profile. 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 Fischer Medical Technologies, Inc. devices

Submission Details

510(k) Number K991293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1999
Decision Date May 05, 2000
Days to Decision 386 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 125d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1750
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 - JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)

Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K991293.
Bloom2 Programmable Electrophysiology Stimulator
K173439 · Fischer Medical · Mar 2018
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K844815 · Cordis Corp. · Jun 1985
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
K851091 · Medtronic Vascular · Apr 1985
PROGRAMMABLE STIMULATOR 5326
K843718 · Medtronic Vascular · Sep 1984
PROGRAMMABLE STIMULATOR 2352
K833421 · Medtronic Vascular · Jan 1984