Cleared Traditional

K830477 - CARDIOMEMO III

K830477 is an FDA 510(k) clearance for CARDIOMEMO III, manufactured by Instromedix, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K830477 · Instromedix, Inc. · Cardiovascular device
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May 1983
Decision
83d
Days
Class 2
Risk

K830477 is an FDA 510(k) clearance for the CARDIOMEMO III. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Instromedix, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 83 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 Instromedix, Inc. devices

FDA 510(k) Submission Details - K830477

510(k) Number K830477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date May 09, 1983
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
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 113
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K830477.
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
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K821726 · Intermedics, Inc. · Jul 1982