Cleared Traditional

K842334 - LIFE MONITOR I

K842334 is the FDA 510(k) clearance for LIFE MONITOR I by St. Croix Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K842334 · St. Croix Medical Systems, Inc. · Anesthesiology device
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Aug 1984
Decision
78d
Days
Class 2
Risk

K842334 is an FDA 510(k) clearance for the LIFE MONITOR I. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by St. Croix Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1984 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 St. Croix Medical Systems, Inc. devices

Submission Details

510(k) Number K842334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1984
Decision Date August 30, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 82
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K842334.
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CAPNOGRAPH
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