Cleared Traditional

ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE (K900385) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900385 · Parexel Intl. Corp. · Cardiovascular device
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Jul 1991
Decision
526d
Days
Class 2
Risk

K900385 is an FDA 510(k) clearance for the ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Parexel Intl. Corp. (Cambridge, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Parexel Intl. Corp. devices

Submission Details

510(k) Number K900385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date July 09, 1991
Days to Decision 526 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
401d slower than avg
Panel avg: 125d · This submission: 526d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K900385.
ORG-8200A UNIVERSAL SIGNAL HOUSING
K912744 · Nihon Kohden America, Inc. · Dec 1991
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451 · Hewlett-Packard Co. · Oct 1991
Q-SMART HOLTER SYSTEMS
K910808 · Quinton, Inc. · Jul 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490 · Hewlett-Packard Co. · Apr 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291 · Hewlett-Packard Co. · Apr 1991
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692 · Nihon Kohden America, Inc. · Oct 1989