Cleared Traditional

K883402 - EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)

K883402 is an FDA 510(k) clearance for EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER), manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K883402 · Quinton, Inc. · Cardiovascular device
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Jan 1989
Decision
166d
Days
Class 2
Risk

K883402 is an FDA 510(k) clearance for the EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on January 17, 1989 after a review of 166 days - an extended review cycle.

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. Standard predicate reliance. 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K883402

510(k) Number K883402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1988
Decision Date January 17, 1989
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 125d · This submission: 166d
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 429
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K883402.
TYPE 9040 SYSTEM ATHENA
K884116 · S & W Medico Teknik · Apr 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989
PATIENT MONITOR MODEL 703
K884662 · Ivy Biomedical Systems, Inc. · Feb 1989
FUKUDA DENSHI MODEL FX-1201
K884992 · Fukuda Denshi USA, Inc. · Jan 1989
Q5000 ST/HR SLOPE MODIFICATION
K883468 · Quinton, Inc. · Dec 1988
CARDIOCAP(TM) CTO-104 MONITOR
K884956 · Datex Division Instrumentarium Corp. · Dec 1988