Cleared Traditional

K860124 - HORIZON 2000 TRANSCUTANEOUS GAS MONITORING

K860124 is an FDA 510(k) clearance for HORIZON 2000 TRANSCUTANEOUS GAS MONITORING, manufactured by Mennen Medical, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K860124

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.

KLK Device Classification - Class 2, Special Controls

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 34
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