Cleared Traditional

K941762 - INTERGRATED MONITORING ARCHIVING AND CO...

K941762 is an FDA 510(k) clearance for INTERGRATED MONITORING ARCHIVING AND CO..., manufactured by Hogan & Hartson. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K941762 · Hogan & Hartson · Cardiovascular device
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Feb 1995
Decision
317d
Days
Class 2
Risk

K941762 is an FDA 510(k) clearance for the INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, D.C., US). The FDA issued a Cleared decision on February 22, 1995 after a review of 317 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: 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 Hogan & Hartson devices

FDA 510(k) Submission Details - K941762

510(k) Number K941762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date February 22, 1995
Days to Decision 317 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
192d slower than avg
Panel avg: 125d · This submission: 317d
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 261
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K941762.
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ACCUSTRESS EXERCISE TESTING SYSTEM
K953127 · Hewlett-Packard Co. · Feb 1996
ALTAIR-DISC RECORDER
K942565 · Burdick Corp. · Dec 1994
PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS
K920587 · Siemens Medical Solutions USA, Inc. · Jan 1993
CENTRA II ANALYSIS SYSTEM
K922171 · Marquette Electronics, Inc. · Dec 1992