Cleared Traditional

K911874 - SLEEPTRACE 2000

K911874 is an FDA 510(k) clearance for SLEEPTRACE 2000, manufactured by Areca Science Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 423-day FDA review.

K911874 · Areca Science Corp. · Anesthesiology device
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Jun 1992
Decision
423d
Days
Class 2
Risk

K911874 is an FDA 510(k) clearance for the SLEEPTRACE 2000. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Areca Science Corp. (Palo Alto, US). The FDA issued a Cleared decision on June 25, 1992 after a review of 423 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.

FDA 510(k) Submission Details - K911874

510(k) Number K911874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date June 25, 1992
Days to Decision 423 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 140d · This submission: 423d
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 119
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K911874.
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · Merit Medical Systems, Inc. · Jan 1993
CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
K923402 · Pro-Tech, Inc. · Dec 1992
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K913749 · Edentec Corp. · Jul 1992
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415 · Medtronic Vascular · Aug 1991
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · Edentec Corp. · Jun 1991
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K905520 · Synectics-Dantec · Apr 1991