Cleared Traditional

K954168 - E100A PULSE OXIMETER FINGER SENSOR/PROBE

K954168 is an FDA 510(k) clearance for E100A PULSE OXIMETER FINGER SENSOR/PROBE, manufactured by Epic Medical Equipment Services, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 373-day FDA review.

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

FDA 510(k) Submission Details - K954168

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
233d slower than avg
Panel avg: 140d · This submission: 373d
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 511
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K954168.
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
K963707 · Nellcor Puritan Bennett, Inc. · Dec 1996
OXI TEMP
K963496 · Bci Intl., Inc. · Nov 1996
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
3304 PULSE OXIMETER
K962156 · Bci Intl., Inc. · Aug 1996
SCORE SOFTWARE
K961450 · Nellcor Puritan Bennett, Inc. · Aug 1996
OXITEMP, 3301T SA
K960058 · Bci Intl., Inc. · May 1996