Cleared Traditional

K962781 - COROMETRICS MODEL 510 AND 511 MONITOR

K962781 is an FDA 510(k) clearance for COROMETRICS MODEL 510 AND 511 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 232-day FDA review.

K962781 · Ge Medical Systems Information Technologies · Anesthesiology device
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Mar 1997
Decision
232d
Days
Class 2
Risk

K962781 is an FDA 510(k) clearance for the COROMETRICS MODEL 510 AND 511 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 March 6, 1997 after a review of 232 days - an extended review 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: 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 - K962781

510(k) Number K962781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 17, 1996
Decision Date March 06, 1997
Days to Decision 232 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
92d slower than avg
Panel avg: 140d · This submission: 232d
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 K962781.
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550 · Respironics, Inc. · Oct 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
K981728 · Alexander Mfg. Co. · Jun 1998
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
K961972 · Aequitron Medical, Inc. · Apr 1997
MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995
MODEL 511 INFANT MONITOR
K942170 · Ge Medical Systems Information Technologies · Jun 1995
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
K930790 · Bio-Logic Systems Corp. · Jan 1994