Cleared Traditional

K901774 - HORIZON 2000 PULSE OXIMETRY (SAO2) MONI...

K901774 is the FDA 510(k) clearance for HORIZON 2000 PULSE OXIMETRY (SAO2) MONI... by Mennen Medical, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K901774 · Mennen Medical, Inc. · Anesthesiology device
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May 1990
Decision
33d
Days
Class 2
Risk

K901774 is an FDA 510(k) clearance for the HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on May 22, 1990 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 K901774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1990
Decision Date May 22, 1990
Days to Decision 33 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
107d faster than avg
Panel avg: 140d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 444
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K901774.
ITC ANGIOGRAPHIC CATHETER
K900757 · Interventional Therapeutics Corp. · Aug 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · Hewlett-Packard Co. · Jul 1990
PULSE OXIMETRY MODULE
K901071 · Marquette Electronics, Inc. · Jun 1990
OXYTRAK(TM) PULSE OXIMETER
K894100 · Critikon Company, LLC · May 1990
MODEL 90489 PULSE OXIMETER MODULE
K901209 · Spacelabs, Inc. · Apr 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · Nonin Medical, Inc. · Feb 1990