Cleared Traditional

K922703 - THE ACTA FORMULA

K922703 is an FDA 510(k) clearance for THE ACTA FORMULA, 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 326-day FDA review.

K922703 · Biosound, Inc. · Cardiovascular device
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Apr 1993
Decision
326d
Days
Class 2
Risk

K922703 is an FDA 510(k) clearance for the THE ACTA FORMULA. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 27, 1993 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K922703

510(k) Number K922703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date April 27, 1993
Days to Decision 326 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
201d slower than avg
Panel avg: 125d · This submission: 326d
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 K922703.
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MORTARA INSTRUMENT, INC. E-SCRIBE
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KING OF HEARTS SCEPTER
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