Cleared Traditional

K991293 - EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR

K991293 is an FDA 510(k) clearance for EPSTIM ELECTROPHYSIOLOGY STIMULATOR CON..., manufactured by Fischer Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 386-day FDA review.

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.

FDA 510(k) Submission Details - K991293

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
Combination Product No
PCCP Authorized No
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.

JOQ Device Classification - Class 2, Special Controls

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)

All 17
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K991293.
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K040207 · Ep Medsystems · Feb 2004
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K011826 · Micropace Pty, Ltd. · Jan 2002
PACE-1A CARDIAC STIMULATOR
K963579 · Radionics, Inc. · Nov 1996
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR
K935590 · Ep Medical, Inc. · May 1994
CONSTANT CURRENT STIMULATOR MODEL 022101
K900553 · Ep Technologies, Inc. · Mar 1990
K991293 · EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
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