Cleared Traditional

K922291 - PERSONAL 120/210 LAPTOP STRESS OPTION

K922291 is an FDA 510(k) clearance for PERSONAL 120/210 LAPTOP STRESS OPTION, manufactured by Biosound, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K922291 · Biosound, Inc. · Cardiovascular device
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Nov 1992
Decision
173d
Days
Class 2
Risk

K922291 is an FDA 510(k) clearance for the PERSONAL 120/210 LAPTOP STRESS OPTION. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 4, 1992 after a review of 173 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 Biosound, Inc. devices

FDA 510(k) Submission Details - K922291

510(k) Number K922291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date November 04, 1992
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 268
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K922291.
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MORTARA INSTRUMENT ST CENTRAL STATION
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TYPE 9050/NEO
K912183 · S & W Medico Teknik · Jun 1992
ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS
K920364 · Biosound, Inc. · Mar 1992
HL-300 RECEIVER MODULE
K915879 · Fukuda Denshi USA, Inc. · Jan 1992