Cleared Traditional

K891486 - AR-800PA RESPIRATION MODULE

K891486 is an FDA 510(k) clearance for AR-800PA RESPIRATION MODULE, 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 221-day FDA review.

K891486 · Nihon Kohden America, Inc. · Anesthesiology device
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Oct 1989
Decision
221d
Days
Class 2
Risk

K891486 is an FDA 510(k) clearance for the AR-800PA RESPIRATION MODULE. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 221 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K891486

510(k) Number K891486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date October 24, 1989
Days to Decision 221 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
81d slower than avg
Panel avg: 140d · This submission: 221d
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 K891486.
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120 · S & W Medico Teknik · Jul 1990
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K901656 · Aequitron Medical, Inc. · Jul 1990
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785 · Aequitron Medical, Inc. · Jul 1990
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K884637 · Aequitron Medical, Inc. · Jan 1989
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K881266 · Aequitron Medical, Inc. · Jun 1988
HEALTHDYNE RATE METER
K874814 · Healthdyne, Inc. · Feb 1988