# K100020: DX Series Finger Sensor

- Pathway: 510(k) (Special)
- Applicant: Dixtal Medical, Inc.
- Decided: Mar 8, 2010 after 62 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: 5 generations back to K962603 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993979: MARSPO2, Model 2001, Novametrix Medical Systems, Inc. (2000) Summary page 1.
- K010451: Novametrix Marquette Compatible Sensors, Novametrix Medical Systems, Inc. (2001) Summary page 1.
- (no number) Nellcor DS100A Adult Finger Clip Sensor and D-YS Multisite Sensor: named in the summary without a submission number
- (no number) Philips M1196A Adult SpO2 Clip Sensor, M1191A Soft Glove Sensor (series) and M1194A Ear Clip Sensor: named in the summary without a submission number

## Indications for use
DX Series Pulse Oximeter Sensors are multi-patient-use sensors intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry monitors or modules in multi-parameter systems are indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

Source page: https://510kreport.com/device/K100020
Methodology: https://510kreport.com/methodology