Cleared Traditional

K931900 - COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.

K931900 is an FDA 510(k) clearance for COMPUTER ASSISTED ARCHIVAL TECH. PHYSIO..., manufactured by Archival Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K931900 · Archival Technologies, Inc. · Cardiovascular device
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Mar 1994
Decision
326d
Days
Class 2
Risk

K931900 is an FDA 510(k) clearance for the COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Archival Technologies, Inc. (Winter Park, US). The FDA issued a Cleared decision on March 11, 1994 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 870.1425 - 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 Archival Technologies, Inc. devices

FDA 510(k) Submission Details - K931900

510(k) Number K931900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1993
Decision Date March 11, 1994
Days to Decision 326 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

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 381
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K931900.
EPICARDIA
K952846 · Medicomp, Inc. · Sep 1995
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
K941762 · Hogan & Hartson · Feb 1995
ALTAIR-DISC RECORDER
K942565 · Burdick Corp. · Dec 1994
DUALTHERM(R) CARDIAC OUTPUT COMPUTER
K925285 · B. Braun of America, Inc. · Jul 1993
PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS
K920587 · Siemens Medical Solutions USA, Inc. · Jan 1993
CENTRA II ANALYSIS SYSTEM
K922171 · Marquette Electronics, Inc. · Dec 1992