Cleared Traditional

K803286 - CARDIOMEMO

K803286 is an FDA 510(k) clearance for CARDIOMEMO, manufactured by Instromedix, Inc.. The device is a Class 2 Cardiovascular device with product code KRE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K803286 · Instromedix, Inc. · Cardiovascular device
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Mar 1981
Decision
77d
Days
Class 2
Risk

K803286 is an FDA 510(k) clearance for the CARDIOMEMO. Classified as Analyzer, Pacemaker Generator Function, Indirect (product code KRE), Class II - Special Controls.

Submitted by Instromedix, Inc. (Walker, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3640 - 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.

FDA 510(k) Submission Details - K803286

510(k) Number K803286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1980
Decision Date March 17, 1981
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRE Device Classification - Class 2, Special Controls

Product Code KRE Analyzer, Pacemaker Generator Function, Indirect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3640
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 - KRE Analyzer, Pacemaker Generator Function, Indirect

All 12
Devices cleared under the same product code (KRE) and FDA review panel - the closest regulatory comparables to K803286.
PACEMAKER FUNCTION ANALYZER
K870909 · Paceart, Inc. · Apr 1987
PACEMAKER SYS ANALYZER #384
K833647 · Pacesetter Systems · Dec 1983
PACEMAKER SYS. ANALYZER 378
K832959 · Siemens Elema AB · Nov 1983
ELECTRONIC PACEMAKER WAVEFORM ANALYZER
K800696 · Instromedix, Inc. · Aug 1980
ULTRA-CHEK PACEMAKER MONITOR
K801022 · Powers Medical Systmes · Jun 1980
PACE-PULSE/COMPUTRAC
K800782 · Bib, Inc. · May 1980
K803286 · CARDIOMEMO
Download PDF Instromedix, Inc.