Cleared Traditional

PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE (K040178) - FDA 510(k) Clearance

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

K040178 · S.P.O. Medical Equipment, Ltd. · Anesthesiology device
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Sep 2004
Decision
228d
Days
Class 2
Risk

K040178 is an FDA 510(k) clearance for the PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by S.P.O. Medical Equipment, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on September 10, 2004 after a review of 228 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 S.P.O. Medical Equipment, Ltd. devices

Submission Details

510(k) Number K040178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date September 10, 2004
Days to Decision 228 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
88d slower than avg
Panel avg: 140d · This submission: 228d
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 243
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K040178.
LNOPV AD-L AND PD-L OXIMETRY SENSORS
K050068 · Masimo Corporation · Feb 2005
MASIMO SET RAD 57 PULSE CO-OXIMETER
K042536 · Masimo Corporation · Jan 2005
LNCS OXIMETRY SENSORS
K042346 · Masimo Corporation · Sep 2004
PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200
K032831 · Conmed Corporation · Aug 2004
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
K041674 · Philips Medical Systems · Jul 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979 · Philips Medical Systems, Inc. · Feb 2004