Cleared Traditional

K900730 - ARVEE APNEA MONITOR, MODEL 4800

K900730 is an FDA 510(k) clearance for ARVEE APNEA MONITOR, manufactured by Arvee Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K900730 · Arvee Medical, Inc. · Anesthesiology device
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Jun 1990
Decision
119d
Days
Class 2
Risk

K900730 is an FDA 510(k) clearance for the ARVEE APNEA MONITOR, MODEL 4800. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Arvee Medical, Inc. (Battle Creek, US). The FDA issued a Cleared decision on June 14, 1990 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K900730

510(k) Number K900730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1990
Decision Date June 14, 1990
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
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 122
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K900730.
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
KNIGHTWATCH SYSTEM
K896934 · Createch Corp. · Jun 1990
'APNEA-ELECTRODE'
K900826 · Medical Science Products, Inc. · Apr 1990
MESAM RECORDER
K894641 · Madaus Medtec, Inc. · Jan 1990
AR-800PA RESPIRATION MODULE
K891486 · Nihon Kohden America, Inc. · Oct 1989
K900730 · ARVEE APNEA MONITOR, MODEL 4800
Download PDF Arvee Medical, Inc.