Cleared Traditional

K850504 - COROMETRICS 500 INFANT MONITOR

K850504 is an FDA 510(k) clearance for COROMETRICS 500 INFANT MONITOR, 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 136-day FDA review.

K850504 · Ge Medical Systems Information Technologies · Anesthesiology device
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Jun 1985
Decision
136d
Days
Class 2
Risk

K850504 is an FDA 510(k) clearance for the COROMETRICS 500 INFANT MONITOR. 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 June 24, 1985 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K850504

510(k) Number K850504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date June 24, 1985
Days to Decision 136 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
4d faster than avg
Panel avg: 140d · This submission: 136d
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 K850504.
MONAGHAN RVM, MODEL 760 OR MODEL 761
K853047 · Monaghan Medical Corp. · Nov 1985
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K851889 · Clinical Data, Inc. · Oct 1985
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · Aequitron Medical, Inc. · Aug 1985
RESPIRATION & HEART RATE MONITOR 530
K843681 · Tri-Med, Inc. · Dec 1984
INFANT MONITOR 16900
K843546 · Healthdyne, Inc. · Oct 1984
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983