Cleared Traditional

K922528 - CMS SYSTEM

K922528 is an FDA 510(k) clearance for CMS SYSTEM, manufactured by Micromedical Industries, Ltd.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 1079-day FDA review.

K922528 · Micromedical Industries, Ltd. · Cardiovascular device
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May 1995
Decision
1079d
Days
Class 2
Risk

K922528 is an FDA 510(k) clearance for the CMS SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Micromedical Industries, Ltd. (Northbrook, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 1079 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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.

FDA 510(k) Submission Details - K922528

510(k) Number K922528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1992
Decision Date May 12, 1995
Days to Decision 1079 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
954d slower than avg
Panel avg: 125d · This submission: 1079d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 436
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K922528.
CARTO SYSTEM
K954395 · Biosense, Ltd. · Dec 1995
EPICARDIA
K952846 · Medicomp, Inc. · Sep 1995
PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400
K945985 · Burdick, Inc. · Jul 1995
EMI MODEL FFF-IA
K952164 · New York Heart Instruments, Inc. · May 1995
HOLTER FOR WINDOWS
K930564 · North East Monitoring, Inc. · Apr 1995
SIEMENS CLINICAL WORK STATION
K935043 · Siemens Medical Electronics · Apr 1995
K922528 · CMS SYSTEM
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