Cleared Traditional

K924875 - MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS

K924875 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 654-day FDA review.

K924875 · Synectics-Dantec · Anesthesiology device
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Jun 1994
Decision
654d
Days
Class 2
Risk

K924875 is an FDA 510(k) clearance for the MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS. 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 June 30, 1994 after a review of 654 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Synectics-Dantec devices

FDA 510(k) Submission Details - K924875

510(k) Number K924875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 14, 1992
Decision Date June 30, 1994
Days to Decision 654 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
514d slower than avg
Panel avg: 140d · This submission: 654d
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 K924875.
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MODEL MEDILOG RAPIDE
K923737 · Oxford Medilog, Inc. · Jan 1994
EDENTEC MODEL 3710 I DIGITAL PRINTER
K921819 · Edentec Corp. · Oct 1993