Cleared Traditional

K893133 - HORIZON 2110/HORIZON 2210 264-XXX-XXX/2...

K893133 is the FDA 510(k) clearance for HORIZON 2110/HORIZON 2210 264-XXX-XXX/2... by Mennen Medical, Inc.. It is a Class 2 Anesthesiology device (product code KLK) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K893133 · Mennen Medical, Inc. · Anesthesiology device
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Jul 1989
Decision
80d
Days
Class 2
Risk

K893133 is an FDA 510(k) clearance for the HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX. 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 July 14, 1989 after a review of 80 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 Mennen Medical, Inc. devices

Submission Details

510(k) Number K893133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date July 14, 1989
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
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 K893133.
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K870805 · Novametrix Medical Systems, Inc. · May 1987
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K861861 · Ge Medical Systems Information Technologies · Jul 1986
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K860124 · Mennen Medical, Inc. · May 1986