Cleared Special

DIXTAL DZ-4100 SERIES PULSE OXIMETER (K103285) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K103285 · Dixtal Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 2011
Decision
259d
Days
Class 2
Risk

K103285 is an FDA 510(k) clearance for the DIXTAL DZ-4100 SERIES PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Dixtal Medical, Inc. (Wallingford, US). The FDA issued a Cleared decision on July 25, 2011 after a review of 259 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dixtal Medical, Inc. devices

Submission Details

510(k) Number K103285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2010
Decision Date July 25, 2011
Days to Decision 259 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Modification to existing cleared device.

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 238
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K103285.
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · Taidoc Technology Corporation · Nov 2011
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
K111621 · Masimo Corporation · Oct 2011
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
K111888 · Masimo Corporation · Sep 2011
MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · Masimo Corporation · Mar 2011
VITAL SIGNS MONITOR
K102835 · Edan Instruments, Inc. · Dec 2010
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
K101012 · Taidoc Technology Corporation · Dec 2010