Cleared Traditional

SPO2 WRAP SENSOR (K002848) - FDA 510(k) Clearance

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

K002848 · Epic Medical Equipment Services, Inc. · Anesthesiology device
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May 2001
Decision
253d
Days
Class 2
Risk

K002848 is an FDA 510(k) clearance for the SPO2 WRAP SENSOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Epic Medical Equipment Services, Inc. (Plano, US). The FDA issued a Cleared decision on May 24, 2001 after a review of 253 days - an extended review 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: 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.

View all Epic Medical Equipment Services, Inc. devices

Submission Details

510(k) Number K002848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date May 24, 2001
Days to Decision 253 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
114d slower than avg
Panel avg: 139d · This submission: 253d
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 159
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K002848.
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · Siemens Medical Solutions USA, Inc. · Jun 2003
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
K022766 · Siemens Medical Solutions USA, Inc. · Sep 2002
INFINITY MICRO2+
K012770 · Siemens Medical Solutions USA, Inc. · Jul 2002
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · Nihon Kohden America, Inc. · Jan 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K991661 · Siemens Medical Solutions USA, Inc. · May 1999
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · Nihon Kohden America, Inc. · Jun 1998