Cleared Traditional

K981725 - OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700

K981725 is an FDA 510(k) clearance for OPTOVENT RESPIRATORY MONITOR MODEL NUMB..., manufactured by Optovent, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K981725 · Optovent, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
263d
Days
Class 2
Risk

K981725 is an FDA 510(k) clearance for the OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Optovent, Inc. (Fort Lee, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 263 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 Optovent, Inc. devices

FDA 510(k) Submission Details - K981725

510(k) Number K981725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1998
Decision Date February 02, 1999
Days to Decision 263 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 140d · This submission: 263d
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 98
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K981725.
PNEUMOTHERML, MODEL: 5800
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GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K983449 · Gereonics, Inc. · Feb 1999
ULTIMA AIRFLOW PRESSURE SENSOR
K984431 · Braebon Medical Corp. · Dec 1998
ULTIMA AIRFLOW SENSOR, 0510
K981445 · Braebon Medical Corp. · Oct 1998
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998