Cleared Traditional

K913749 - EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170

K913749 is an FDA 510(k) clearance for EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLO..., manufactured by Edentec Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K913749 · Edentec Corp. · Anesthesiology device
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Jul 1992
Decision
316d
Days
Class 2
Risk

K913749 is an FDA 510(k) clearance for the EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on July 2, 1992 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Edentec Corp. devices

FDA 510(k) Submission Details - K913749

510(k) Number K913749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1991
Decision Date July 02, 1992
Days to Decision 316 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
176d slower than avg
Panel avg: 140d · This submission: 316d
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 86
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K913749.
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MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · Edentec Corp. · Jun 1991
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K905520 · Synectics-Dantec · Apr 1991