Cleared Special

K041674 - THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT

K041674 is an FDA 510(k) clearance for THE M3810A PHILIPS TELEMONITORING SYSTE..., manufactured by Philips Medical Systems. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 28-day FDA review.

K041674 · Philips Medical Systems · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
28d
Days
Class 2
Risk

K041674 is an FDA 510(k) clearance for the THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 19, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041674

510(k) Number K041674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2004
Decision Date July 19, 2004
Days to Decision 28 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K041674.
SPOT CHECK PULSE OXIMETER,512/513
K032949 · Respironics Novametrix, Inc. · Aug 2004
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
K041644 · Elekon Industries U.S.A., Inc. · Jul 2004
LNCS OXIMETRY SENSORS
K041815 · Masimo Corp. · Jul 2004
NC SP02 ADAPTER CABLE
K041204 · Masimo Corp. · Jun 2004
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
K041156 · Nonin Medical, Inc. · Jun 2004
MODIFICATION TO AVANT 9600 PULSE OXIMETER
K040589 · Nonin Medical, Inc. · Jun 2004