Cleared Traditional

K862747 - 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS

K862747 is an FDA 510(k) clearance for 8800 SERIES MICRO-PROCESSOR-BASED APNEA..., manufactured by Atlas Researches , Ltd.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 746-day FDA review.

K862747 · Atlas Researches , Ltd. · Anesthesiology device
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Aug 1988
Decision
746d
Days
Class 2
Risk

K862747 is an FDA 510(k) clearance for the 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Atlas Researches , Ltd. (Israel, IL). The FDA issued a Cleared decision on August 5, 1988 after a review of 746 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 Atlas Researches , Ltd. devices

FDA 510(k) Submission Details - K862747

510(k) Number K862747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1986
Decision Date August 05, 1988
Days to Decision 746 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
606d slower than avg
Panel avg: 140d · This submission: 746d
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 109
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K862747.
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