Cleared Traditional

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) (K041647) - FDA 510(k) Clearance

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

K041647 · Elekon Industries U.S.A., Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Sep 2004
Decision
77d
Days
Class 2
Risk

K041647 is an FDA 510(k) clearance for the FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPAT.... 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 2, 2004 after a review of 77 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 Elekon Industries U.S.A., Inc. devices

Submission Details

510(k) Number K041647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2004
Decision Date September 02, 2004
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 243
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K041647.
LNOPV AD-L AND PD-L OXIMETRY SENSORS
K050068 · Masimo Corporation · Feb 2005
MASIMO SET RAD 57 PULSE CO-OXIMETER
K042536 · Masimo Corporation · Jan 2005
LNCS OXIMETRY SENSORS
K042346 · Masimo Corporation · Sep 2004
PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200
K032831 · Conmed Corporation · Aug 2004
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
K041674 · Philips Medical Systems · Jul 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979 · Philips Medical Systems, Inc. · Feb 2004