Cleared Traditional

K173439 - Bloom2 Programmable Electrophysiology Stimulator

K173439 is an FDA 510(k) clearance for Bloom2 Programmable Electrophysiology S..., manufactured by Fischer Medical. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K173439 · Fischer Medical · Cardiovascular device
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Mar 2018
Decision
146d
Days
Class 2
Risk

K173439 is an FDA 510(k) clearance for the Bloom2 Programmable Electrophysiology Stimulator. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Fischer Medical (Wheat Ridge, US). The FDA issued a Cleared decision on March 29, 2018 after a review of 146 days - within the typical 510(k) review window.

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. 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 Fischer Medical devices

FDA 510(k) Submission Details - K173439

510(k) Number K173439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2017
Decision Date March 29, 2018
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
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 Consultant

Hart Consulting, LLC
Charles Mike Hart

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)

All 9
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K173439.
EP-4 CLINICAL STIMUTATOR
K041442 · Ep Medsystems · Sep 2004
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
K991293 · Fischer Medical Technologies, Inc. · May 2000
PACE-1A CARDIAC STIMULATOR
K963579 · Radionics, Inc. · Nov 1996
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · Medtronic Vascular · Aug 1986
EXTERNAL PACEMAKER TELECTRONICS TE200
K852746 · Seamed Corp. · Sep 1985
CORDIS ELECTROPHYSIOLOGY STIMULATOR
K844815 · Cordis Corp. · Jun 1985