Cleared Traditional

K860124 - HORIZON 2000 TRANSCUTANEOUS GAS MONITORING

K860124 is the FDA 510(k) clearance for HORIZON 2000 TRANSCUTANEOUS GAS MONITORING by Mennen Medical, Inc.. It is a Class 2 Anesthesiology device (product code KLK) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K860124 · Mennen Medical, Inc. · Anesthesiology device
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May 1986
Decision
115d
Days
Class 2
Risk

K860124 is an FDA 510(k) clearance for the HORIZON 2000 TRANSCUTANEOUS GAS MONITORING. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 115 days - within the typical 510(k) review window.

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: 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 Mennen Medical, Inc. devices

Submission Details

510(k) Number K860124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date May 09, 1986
Days to Decision 115 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
25d faster than avg
Panel avg: 140d · This submission: 115d
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 32
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K860124.
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K893133 · Mennen Medical, Inc. · Jul 1989
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K870805 · Novametrix Medical Systems, Inc. · May 1987
515A NEO-TRAK NEONATAL MONITOR
K861861 · Ge Medical Systems Information Technologies · Jul 1986
KONTRON CUTANEOUS PO2 MONITOR 820
K860951 · Kontron Instruments, Inc. · Apr 1986
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
K844253 · Novametrix Medical Systems, Inc. · Jan 1985
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
K844079 · Novametrix Medical Systems, Inc. · Nov 1984