Cleared Traditional

K892524 - VITALOGRAPH-BREATHCO MONITOR

K892524 is an FDA 510(k) clearance for VITALOGRAPH-BREATHCO MONITOR, manufactured by Vitalograph , Ltd.. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K892524 · Vitalograph , Ltd. · Anesthesiology device
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May 1989
Decision
24d
Days
Class 2
Risk

K892524 is an FDA 510(k) clearance for the VITALOGRAPH-BREATHCO MONITOR. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on May 5, 1989 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - 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 - K892524

510(k) Number K892524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date May 05, 1989
Days to Decision 24 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
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 23
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K892524.
MICROCO
K950197 · Micro Direct, Inc. · Oct 1996
CO BREATH ANALYSIS MODULE & MONOXOL II
K952694 · Bacharach, Inc. · Jan 1996
CO/CMD-1
K900322 · Spirometrics, Inc. · Apr 1990
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
K863420 · Vitalograph , Ltd. · Jan 1987
CO TEST
K843845 · Erich Jaeger, Inc. · Oct 1984
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K833739 · Instrumentarium Corp. · Dec 1983
K892524 · VITALOGRAPH-BREATHCO MONITOR
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