Cleared Traditional

K875057 - FUKUDA MODEL DS-503 DYNASCOPE PATIENT M...

K875057 is the FDA 510(k) clearance for FUKUDA MODEL DS-503 DYNASCOPE PATIENT M... by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K875057 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Mar 1988
Decision
104d
Days
Class 2
Risk

K875057 is an FDA 510(k) clearance for the FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Kirkland, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 K875057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date March 22, 1988
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K875057.
MINIMON 7131B PATIENT MONITOR
K882197 · Kontron Instruments, Inc. · Aug 1988
MINIMON 7132B PATIENT MONITOR
K882198 · Kontron Instruments, Inc. · Jul 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · Mennen Medical, Inc. · May 1988
MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH
K872658 · Del Mar Avionics · Jan 1988
FITNESS RECUMBENT ERGOMETER, MODEL FT1400
K872548 · Invacare Corp. · Dec 1987
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987