Cleared Traditional

K911386 - SLEEPMASTER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911386 · Biomedical Monitoring Systems, Inc. · Anesthesiology device
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Apr 1992
Decision
393d
Days
Class 2
Risk

K911386 is an FDA 510(k) clearance for the SLEEPMASTER. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Biomedical Monitoring Systems, Inc. (East Lyme, US). The FDA issued a Cleared decision on April 24, 1992 after a review of 393 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Biomedical Monitoring Systems, Inc. devices

Submission Details

510(k) Number K911386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date April 24, 1992
Days to Decision 393 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 139d · This submission: 393d
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 173
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K911386.
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