Cleared Traditional

K942752 - MARQUETTE EAR PROBE SENSOR

K942752 is an FDA 510(k) clearance for MARQUETTE EAR PROBE SENSOR, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Anesthesiology device with product code DPZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K942752 · Marquette Electronics, Inc. · Anesthesiology device
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Sep 1994
Decision
84d
Days
Class 2
Risk

K942752 is an FDA 510(k) clearance for the MARQUETTE EAR PROBE SENSOR. Classified as Oximeter, Ear (product code DPZ), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Jupiter, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2710 - 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K942752

510(k) Number K942752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1994
Decision Date September 02, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPZ Device Classification - Class 2, Special Controls

Product Code DPZ Oximeter, Ear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2710
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 - DPZ Oximeter, Ear

Devices cleared under the same product code (DPZ) and FDA review panel - the closest regulatory comparables to K942752.
FLEXI-STAT SP02 EAR SENSOR
K042675 · Elekon Industries U.S.A., Inc. · Dec 2004
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K040831 · Datex-Ohmeda, Inc. · Sep 2004
DURA-Y OXYGEN TRANSDUCER, EAR CLIP
K944760 · Nellcor, Inc. · Oct 1994
PULSE OXIMETER
K862426 · Draeger Medical, Inc. · Sep 1986
OHMEDA BIOX 3700 PULSE OXIMETER
K850494 · Ohmeda Medical · Mar 1985
EAR OXIMETER
K810363 · Bio-Tek Instruments, Inc. · Feb 1981