Cleared Traditional

DYNASCOPE SERIES (K840055) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840055 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Aug 1984
Decision
229d
Days
Class 2
Risk

K840055 is an FDA 510(k) clearance for the DYNASCOPE SERIES. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1984 after a review of 229 days - an extended review cycle.

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. 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 K840055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date August 22, 1984
Days to Decision 229 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K840055.
MODEL 78353B
K842817 · Hewlett-Packard Co. · Jun 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187 · Siemens Medical Solutions USA, Inc. · Apr 1985
PATIENT MONITOR 78354A
K842236 · Hewlett-Packard Co. · Jan 1985
PATIENT MONITOR 78534B
K840251 · Hewlett-Packard Co. · Feb 1984
PATIENT MONITOR 788 33A
K831943 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78832A
K831944 · Hewlett-Packard Co. · Oct 1983