Cleared Traditional

K042675 - FLEXI-STAT SP02 EAR SENSOR

K042675 is an FDA 510(k) clearance for FLEXI-STAT SP02 EAR SENSOR, manufactured by Elekon Industries U.S.A., Inc.. The device is a Class 2 Anesthesiology device with product code DPZ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K042675 · Elekon Industries U.S.A., Inc. · Anesthesiology device
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Dec 2004
Decision
68d
Days
Class 2
Risk

K042675 is an FDA 510(k) clearance for the FLEXI-STAT SP02 EAR SENSOR. Classified as Oximeter, Ear (product code DPZ), Class II - Special Controls.

Submitted by Elekon Industries U.S.A., Inc. (Plano, US). The FDA issued a Cleared decision on December 6, 2004 after a review of 68 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 Elekon Industries U.S.A., Inc. devices

FDA 510(k) Submission Details - K042675

510(k) Number K042675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date December 06, 2004
Days to Decision 68 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 140d · This submission: 68d
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 K042675.
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K040831 · Datex-Ohmeda, Inc. · Sep 2004
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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