Cleared Traditional

E100A PULSE OXIMETER FINGER SENSOR/PROBE (K954168) - 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 159
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K954168.
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K973222 · Siemens Medical Solutions USA, Inc. · Sep 1997
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992