Cleared Traditional

K882273 - HORIZON 2000 PULSE OXIMETRY AND MODULE

K882273 is the FDA 510(k) clearance for HORIZON 2000 PULSE OXIMETRY AND MODULE by Mennen Medical, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K882273 · Mennen Medical, Inc. · Anesthesiology device
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Aug 1988
Decision
86d
Days
Class 2
Risk

K882273 is an FDA 510(k) clearance for the HORIZON 2000 PULSE OXIMETRY AND MODULE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on August 25, 1988 after a review of 86 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 K882273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date August 25, 1988
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
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 K882273.
BM-103 BATTERY MODULE
K883877 · Datex Division Instrumentarium Corp. · Oct 1988
KONTRON PULSE OXIMETER 7840
K873624 · Kontron Instruments, Inc. · Oct 1988
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · Hewlett-Packard Co. · Oct 1988
SATLITE+/PB251+ PULSE OXIMETER
K881883 · Datex Division Instrumentarium Corp. · Jul 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · Hewlett-Packard Co. · May 1988
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
K874442 · Critikon Company, LLC · Feb 1988