Cleared Traditional

K823220 - COSMOS

K823220 is an FDA 510(k) clearance for COSMOS, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K823220 · Nihon Kohden America, Inc. · Cardiovascular device
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Nov 1982
Decision
23d
Days
Class 2
Risk

K823220 is an FDA 510(k) clearance for the COSMOS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on November 24, 1982 after a review of 23 days - a notably fast clearance cycle.

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: 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 - K823220

510(k) Number K823220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date November 24, 1982
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K823220.
ELECTROCARDIOGRAPH #334
K823488 · Birtcher Corp. · Dec 1982
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · Nihon Kohden America, Inc. · Dec 1982
FULL-DISCLOSURE AMBULATORY ECG SYSTEM
K823529 · Clinical Data, Inc. · Dec 1982
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982
AUTOMATIC SINGLE CHANNEL ECG #399
K821888 · Birtcher Corp. · Jul 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · Nihon Kohden America, Inc. · Feb 1982