Cleared Traditional

K893094 - HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM

K893094 is an FDA 510(k) clearance for HB 1000, manufactured by Heartware Intl. Corp.. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K893094 · Heartware Intl. Corp. · Cardiovascular device
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Oct 1989
Decision
157d
Days
Class 2
Risk

K893094 is an FDA 510(k) clearance for the HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Heartware Intl. Corp. (New York, US). The FDA issued a Cleared decision on October 2, 1989 after a review of 157 days - an extended review cycle.

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 Heartware Intl. Corp. devices

FDA 510(k) Submission Details - K893094

510(k) Number K893094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1989
Decision Date October 02, 1989
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
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 13
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K893094.
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