Cleared Traditional

K173439 - Bloom2 Programmable Electrophysiology S...

K173439 is the FDA 510(k) clearance for Bloom2 Programmable Electrophysiology S... by Fischer Medical. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 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)

Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K173439.
PACE-1A CARDIAC STIMULATOR
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MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
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K844815 · Cordis Corp. · Jun 1985
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K851091 · Medtronic Vascular · Apr 1985
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K843718 · Medtronic Vascular · Sep 1984
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K833421 · Medtronic Vascular · Jan 1984