Cleared Traditional

NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 (K844253) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844253 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Jan 1985
Decision
69d
Days
Class 2
Risk

K844253 is an FDA 510(k) clearance for the NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on January 10, 1985 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - 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 Novametrix Medical Systems, Inc. devices

Submission Details

510(k) Number K844253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1984
Decision Date January 10, 1985
Days to Decision 69 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 140d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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 - KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

All 8
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K844253.
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