Cleared Traditional

K870835 - ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)

K870835 is an FDA 510(k) clearance for ADULT APNEA MONITOR (20), manufactured by Applied Membrane Technology, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K870835 · Applied Membrane Technology, Inc. · Anesthesiology device
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Mar 1987
Decision
24d
Days
Class 2
Risk

K870835 is an FDA 510(k) clearance for the ADULT APNEA MONITOR (20), MONITOR INTERFACE (30). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Applied Membrane Technology, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 24 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K870835

510(k) Number K870835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date March 27, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
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 128
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K870835.
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR
K872954 · Aequitron Medical, Inc. · Oct 1987
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
K871551 · Aequitron Medical, Inc. · Jun 1987
MODEL 2000W OPTION H CONFIGURATION
K871302 · Edentec Corp. · Apr 1987
LIFEWATCH PLUS
K870661 · The Perkin-Elmer Corp. · Mar 1987
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · Nihon Kohden America, Inc. · Feb 1987
KONTRON VITALMON 5010 PATIENT MONITOR
K852249 · Kontron Instruments, Inc. · Oct 1986
K870835 · ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)
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