Cleared Traditional

K812873 - MEDICON #8200 AMS

K812873 is an FDA 510(k) clearance for MEDICON #8200 AMS, manufactured by Medicon, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K812873 · Medicon, Inc. · Anesthesiology device
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Nov 1981
Decision
33d
Days
Class 2
Risk

K812873 is an FDA 510(k) clearance for the MEDICON #8200 AMS. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Medicon, Inc. (Walker, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 33 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 - K812873

510(k) Number K812873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1981
Decision Date November 16, 1981
Days to Decision 33 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 140d · This submission: 33d
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 174
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K812873.
INFANT MONITOR
K820645 · Healthdyne, Inc. · Apr 1982
JLS GROUP INFANT MONITOR
K820374 · Jls Group, Inc. · Mar 1982
INFALERT
K813507 · Briox Technologies, Inc. · Jan 1982
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · Honeywell, Inc. · Oct 1981
INFANT APNEA MONITOR MODEL 100
K812045 · Medix Medical Electronics (U.S.A.), Inc. · Sep 1981
RESPIRATION RATE MONITOR 120/121
K812044 · Medix Medical Electronics (U.S.A.), Inc. · Aug 1981
K812873 · MEDICON #8200 AMS
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