Cleared Traditional

K873791 - MODEL 500E INFANT MONITORING SYSTEM

K873791 is an FDA 510(k) clearance for MODEL 500E INFANT MONITORING SYSTEM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K873791 · Ge Medical Systems Information Technologies · Anesthesiology device
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Nov 1987
Decision
67d
Days
Class 2
Risk

K873791 is an FDA 510(k) clearance for the MODEL 500E INFANT MONITORING SYSTEM. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 67 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K873791

510(k) Number K873791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1987
Decision Date November 23, 1987
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
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 77
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K873791.
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K884637 · Aequitron Medical, Inc. · Jan 1989
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K881266 · Aequitron Medical, Inc. · Jun 1988
HEALTHDYNE RATE METER
K874814 · Healthdyne, Inc. · Feb 1988
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
LIFEWATCH PLUS
K870661 · The Perkin-Elmer Corp. · Mar 1987