Cleared Traditional

K905575 - MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON

K905575 is an FDA 510(k) clearance for MODIFIED MODELS 2000W AND 2000W OPTION ..., 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 190-day FDA review.

K905575 · Edentec Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
190d
Days
Class 2
Risk

K905575 is an FDA 510(k) clearance for the MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON. 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 June 20, 1991 after a review of 190 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 Edentec Corp. devices

FDA 510(k) Submission Details - K905575

510(k) Number K905575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date June 20, 1991
Days to Decision 190 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
50d slower than avg
Panel avg: 140d · This submission: 190d
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 K905575.
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · Merit Medical Systems, Inc. · Jan 1993
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K913749 · Edentec Corp. · Jul 1992
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415 · Medtronic Vascular · Aug 1991
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K905520 · Synectics-Dantec · Apr 1991
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
K903020 · Aequitron Medical, Inc. · Apr 1991
MODEL 900S APNEA/HEART MONITOR
K903287 · Healthdyne, Inc. · Aug 1990