Cleared Traditional

K881831 - WS 800R THERMAL ARRAY RECORDER

K881831 is an FDA 510(k) clearance for WS 800R THERMAL ARRAY RECORDER, manufactured by Nihon Kohden America, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K881831 · Nihon Kohden America, Inc. · Cardiovascular device
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Jul 1988
Decision
76d
Days
Class 1
Risk

K881831 is an FDA 510(k) clearance for the WS 800R THERMAL ARRAY RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on July 14, 1988 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K881831

510(k) Number K881831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1988
Decision Date July 14, 1988
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DSF Recorder, Paper Chart

All 50
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K881831.
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