Cleared Traditional

K003704 - OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)

K003704 is an FDA 510(k) clearance for OPTOVENT RESPONS, manufactured by Optovent AB. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K003704 · Optovent AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
66d
Days
Class 2
Risk

K003704 is an FDA 510(k) clearance for the OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MOD.... Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Optovent AB (Fort Lee, US). The FDA issued a Cleared decision on February 5, 2001 after a review of 66 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.

FDA 510(k) Submission Details - K003704

510(k) Number K003704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2000
Decision Date February 05, 2001
Days to Decision 66 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
74d faster than avg
Panel avg: 140d · This submission: 66d
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 174
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K003704.
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
K062883 · Gereonics, Inc. · Jun 2007
ANDROFLOW - RESPIRATORY RATE MONITOR
K051779 · Andromed, Inc. · Sep 2005
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
K040605 · Dymedix, Inc. · Apr 2004
ULTIMA SMARTBELT, MODEL 0560
K001743 · Braebon Medical Corp. · Aug 2000
RESPIRATORY BELT SENSOR, MODEL 6000S
K001030 · Dymedix, Inc. · May 2000
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411 · Gereonics, Inc. · Apr 1999
K003704 · OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
Download PDF Optovent AB