Cleared Traditional

K964888 - HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II

K964888 is an FDA 510(k) clearance for HEART AIDE MULTPLE/HEART AIDE PLUS/HEAR..., manufactured by Tz Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K964888 · Tz Medical, Inc. · Cardiovascular device
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Feb 1997
Decision
84d
Days
Class 2
Risk

K964888 is an FDA 510(k) clearance for the HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Tz Medical, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on February 28, 1997 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tz Medical, Inc. devices

FDA 510(k) Submission Details - K964888

510(k) Number K964888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1996
Decision Date February 28, 1997
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 135
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K964888.
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ACCELERATED TRANSMISSION PROTOCOL
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