Cleared Traditional

K964593 - DIASCOPE TRAVELLER PLUS (4053)

K964593 is the FDA 510(k) clearance for DIASCOPE TRAVELLER PLUS (4053) by S & W Medico Teknik A/S. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K964593 · S & W Medico Teknik A/S · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
227d
Days
Class 2
Risk

K964593 is an FDA 510(k) clearance for the DIASCOPE TRAVELLER PLUS (4053). Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by S & W Medico Teknik A/S (Albertslund, DK). The FDA issued a Cleared decision on June 30, 1997 after a review of 227 days - an extended review cycle.

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: 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 S & W Medico Teknik A/S devices

Submission Details

510(k) Number K964593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date June 30, 1997
Days to Decision 227 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
102d slower than avg
Panel avg: 125d · This submission: 227d
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 119
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K964593.
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624 · Siemens Medical Solutions USA, Inc. · Sep 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348 · Siemens Medical Solutions USA, Inc. · Aug 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K970920 · Siemens Medical Solutions USA, Inc. · Jul 1997
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
K965062 · Siemens Medical Solutions USA, Inc. · Jun 1997
HEWLETT-PACKARD CENTRALVUE SOFTWARE
K964832 · Hewlett-Packard Co. · May 1997
ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
K962827 · Marquette Electronics, Inc. · Feb 1997