Cleared Traditional

K041522 - FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS

K041522 is an FDA 510(k) clearance for FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS, manufactured by Elekon Industries U.S.A., Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K041522 · Elekon Industries U.S.A., Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
99d
Days
Class 2
Risk

K041522 is an FDA 510(k) clearance for the FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Elekon Industries U.S.A., Inc. (Plano, US). The FDA issued a Cleared decision on September 14, 2004 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K041522

510(k) Number K041522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date September 14, 2004
Days to Decision 99 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
41d faster than avg
Panel avg: 140d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K041522.
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
K042306 · Philips Medizin Systeme Boeblingen GmbH · Oct 2004
ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
K042501 · Hitachi Medical Corp. · Oct 2004
LNCS OXIMETRY SENSORS
K042346 · Masimo Corporation · Sep 2004
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
K041964 · Mediaid, Inc. · Sep 2004
PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
K040178 · S.P.O. Medical Equipment, Ltd. · Sep 2004
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
K041647 · Elekon Industries U.S.A., Inc. · Sep 2004