Cleared Traditional

K853084 - MEDICON MODEL 8200 AMS(APNEA MONITOR SY...

K853084 is the FDA 510(k) clearance for MEDICON MODEL 8200 AMS(APNEA MONITOR SY... by Aequitron Medical, Inc.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K853084 · Aequitron Medical, Inc. · Anesthesiology device
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Aug 1985
Decision
10d
Days
Class 2
Risk

K853084 is an FDA 510(k) clearance for the MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 2, 1985 after a review of 10 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.

View all Aequitron Medical, Inc. devices

Submission Details

510(k) Number K853084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date August 02, 1985
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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 36
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K853084.
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