Cleared Traditional

K905520 - MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION

K905520 is an FDA 510(k) clearance for MICROTRAPPER/MICRODIGITRAPPER, manufactured by Synectics-Dantec. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K905520 · Synectics-Dantec · Anesthesiology device
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Apr 1991
Decision
140d
Days
Class 2
Risk

K905520 is an FDA 510(k) clearance for the MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on April 26, 1991 after a review of 140 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.

View all Synectics-Dantec devices

FDA 510(k) Submission Details - K905520

510(k) Number K905520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date April 26, 1991
Days to Decision 140 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
At panel average
Panel avg: 140d · This submission: 140d
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 K905520.
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MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · Edentec Corp. · Jun 1991
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
K903020 · Aequitron Medical, Inc. · Apr 1991
MODEL 900S APNEA/HEART MONITOR
K903287 · Healthdyne, Inc. · Aug 1990
R-BAND(TM) RESPIRATORY SENSOR
K900264 · Buckman Co., Inc. · Jul 1990