# K103285: Dixtal DZ-4100 Series Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Dixtal Medical, Inc.
- Decided: Jul 25, 2011 after 259 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K941811 (1994). 176 ancestors in all.
No later device cites it as a predicate yet.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082280: Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor, Philips Medical Systems North America Co. (2008) Summary page 1.
- K081937: Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2  Pulse Oximetry Module, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 1.

## Indications for use
The Dixtal DX-4100 Series Pulse Oximeter monitors are intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry is indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

Source page: https://510kreport.com/device/K103285
Methodology: https://510kreport.com/methodology