Cleared Traditional

K823563 - EEG & RESPIRATION MODULES POLYGRAPH

K823563 is an FDA 510(k) clearance for EEG & RESPIRATION MODULES POLYGRAPH, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K823563 · Nihon Kohden America, Inc. · Anesthesiology device
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Jan 1983
Decision
41d
Days
Class 2
Risk

K823563 is an FDA 510(k) clearance for the EEG & RESPIRATION MODULES POLYGRAPH. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on January 12, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device 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 - K823563

510(k) Number K823563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1982
Decision Date January 12, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 77
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K823563.
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
RESPIRATION & HEART RATE MONITOR 530
K843681 · Tri-Med, Inc. · Dec 1984
INFANT MONITOR 16900
K843546 · Healthdyne, Inc. · Oct 1984
TRIMED 510 APNEA MONITOR
K822819 · Tri-Med, Inc. · Nov 1982
HEALTHDYNE MODEL 16900 INFANT MONITOR
K821731 · Healthdyne, Inc. · Jul 1982
INFANT MONITOR
K820645 · Healthdyne, Inc. · Apr 1982