Cleared Traditional

K042675 - FLEXI-STAT SP02 EAR SENSOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042675 · Elekon Industries U.S.A., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
71d faster than avg
Panel avg: 139d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.