Cleared Traditional

K905520 - MICROTRAPPER/MICRODIGITRAPPER

K905520 is the FDA 510(k) clearance for MICROTRAPPER/MICRODIGITRAPPER by Synectics-Dantec. It is a Class 2 Anesthesiology device (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

Submission Details

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
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.

Device Classification

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 36
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K905520.
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K891486 · Nihon Kohden America, Inc. · Oct 1989
MODEL 500E INFANT MONITORING SYSTEM
K873791 · Ge Medical Systems Information Technologies · Nov 1987