Cleared Traditional

K954168 - E100A PULSE OXIMETER FINGER SENSOR/PROBE (FDA 510(k) Clearance)

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

K954168 · Epic Medical Equipment Services, Inc. · Anesthesiology device
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Sep 1996
Decision
373d
Days
Class 2
Risk

K954168 is an FDA 510(k) clearance for the E100A PULSE OXIMETER FINGER SENSOR/PROBE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Epic Medical Equipment Services, Inc. (Dallas, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K954168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date September 12, 1996
Days to Decision 373 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 139d · This submission: 373d
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 723
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K954168.
Nasal Alar SpO2 Sensor (989803205381)
K253887 · Philips Medizin Systeme · May 2026
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
K260931 · Unimed Medical Supplies, Inc. · Apr 2026
AViTA Pulse Oximeter (SP61)
K252448 · Avita Corporation · Feb 2026
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47
K253109 · Shenzhen Best Electronics Co., Ltd. · Jan 2026
Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025