Cleared Traditional

K853352 - FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT...

K853352 is the FDA 510(k) clearance for FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT... by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K853352 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Nov 1985
Decision
94d
Days
Class 2
Risk

K853352 is an FDA 510(k) clearance for the FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR. 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 November 14, 1985 after a review of 94 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

Submission Details

510(k) Number K853352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date November 14, 1985
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 231
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K853352.
MEDILOG 4500 SYSTEM
K860079 · Oxford Medilog, Inc. · Feb 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · Fukuda Denshi USA, Inc. · Feb 1986
MEDILOG M6
K852892 · Oxford Medilog, Inc. · Dec 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · Fukuda Denshi USA, Inc. · Oct 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