Cleared Traditional

K853213 - FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON

K853213 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE ..., manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K853213 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Oct 1985
Decision
144d
Days
Class 2
Risk

K853213 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Kirkland, US). The FDA issued a Cleared decision on October 11, 1985 after a review of 144 days - within the typical 510(k) review window.

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 Fukuda Denshi USA, Inc. devices

FDA 510(k) Submission Details - K853213

510(k) Number K853213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date October 11, 1985
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 299
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K853213.
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · Fukuda Denshi USA, Inc. · Feb 1986
MEDILOG M6
K852892 · Oxford Medilog, Inc. · Dec 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · Fukuda Denshi USA, Inc. · Nov 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · Hewlett-Packard Co. · Sep 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · Nihon Kohden America, Inc. · Jul 1985
MORTARA INSTRUMENT MODEL EL-1
K851702 · Mortara Instrument, Inc. · Jul 1985