Cleared Traditional

K923221 - KING OF HEARTS SCEPTER

K923221 is the FDA 510(k) clearance for KING OF HEARTS SCEPTER by Instromedix, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K923221 · Instromedix, Inc. · Cardiovascular device
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Mar 1993
Decision
250d
Days
Class 2
Risk

K923221 is an FDA 510(k) clearance for the KING OF HEARTS SCEPTER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Instromedix, Inc. (Hillsboro, US). The FDA issued a Cleared decision on March 8, 1993 after a review of 250 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Instromedix, Inc. devices

Submission Details

510(k) Number K923221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date March 08, 1993
Days to Decision 250 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 125d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 253
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K923221.
THE ACTA FORMULA
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9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
K930134 · S & W Medico Teknik · Apr 1993
MORTARA INSTRUMENT ST CENTRAL STATION
K922927 · Mortara Instrument, Inc. · Nov 1992
PERSONAL 120/210 LAPTOP STRESS OPTION
K922291 · Biosound, Inc. · Nov 1992
TYPE 9050/NEO
K912183 · S & W Medico Teknik · Jun 1992