Cleared Traditional

K875057 - FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR

K875057 is an FDA 510(k) clearance for FUKUDA MODEL DS-503 DYNASCOPE PATIENT M..., manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K875057

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.

DPS Device Classification - Class 2, Special Controls

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 418
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K875057.
MINIMON 7132B PATIENT MONITOR
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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