Cleared Special

K012333 - FLEXI-SITE SP02 EAR SENSOR

K012333 is an FDA 510(k) clearance for FLEXI-SITE SP02 EAR SENSOR, manufactured by Epic Medical Equipment Services, Inc.. The device is a Class 2 Anesthesiology device with product code DPZ cleared through the Special 510(k) pathway after a 85-day FDA review.

K012333 · Epic Medical Equipment Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
85d
Days
Class 2
Risk

K012333 is an FDA 510(k) clearance for the FLEXI-SITE SP02 EAR SENSOR. Classified as Oximeter, Ear (product code DPZ), Class II - Special Controls.

Submitted by Epic Medical Equipment Services, Inc. (Plano, US). The FDA issued a Cleared decision on October 17, 2001 after a review of 85 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012333

510(k) Number K012333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2001
Decision Date October 17, 2001
Days to Decision 85 days
Submission Type Special
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
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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

All 9
Devices cleared under the same product code (DPZ) and FDA review panel - the closest regulatory comparables to K012333.
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
FLEXI-SITE SP02 EAR SENSOR
K010718 · Epic Medical Equipment Services, Inc. · Mar 2001
DURA-Y OXYGEN TRANSDUCER, EAR CLIP
K944760 · Nellcor, Inc. · Oct 1994
MARQUETTE EAR PROBE SENSOR
K942752 · Marquette Electronics, Inc. · Sep 1994
PULSE RATE MONITOR
K914595 · Fitness Quest, Inc. · Jan 1992
K012333 · FLEXI-SITE SP02 EAR SENSOR
Download PDF FDA Summary Epic Medical Equipmen…