Cleared Traditional

K833689 - DIASCOPE 2

K833689 is an FDA 510(k) clearance for DIASCOPE 2, manufactured by S & W Medico Teknik. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K833689 · S & W Medico Teknik · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
374d
Days
Class 2
Risk

K833689 is an FDA 510(k) clearance for the DIASCOPE 2. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by S & W Medico Teknik (Walker, US). The FDA issued a Cleared decision on October 26, 1984 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 S & W Medico Teknik devices

FDA 510(k) Submission Details - K833689

510(k) Number K833689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date October 26, 1984
Days to Decision 374 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
249d slower than avg
Panel avg: 125d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 201
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K833689.
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · Nihon Kohden America, Inc. · Jan 1985
DYNASCOPE MONITOR DS-800
K844348 · Fukuda Denshi USA, Inc. · Dec 1984
SERVOMED PULSE AMPLIFIER MODULE-206-
K840523 · Litton Medical Electronics · Oct 1984
SERVOMED BASIC BEDSIDE UNIT SMV 110TP
K840524 · Litton Medical Electronics · Oct 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · Aequitron Medical, Inc. · Oct 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832 · Litton Medical Electronics · Sep 1984