# K993555: Masimo Set/Quartz 2500 Pulse Oximeter and Accessories

- Pathway: 510(k) (Special)
- Applicant: Masimo Corp.
- Decided: Nov 19, 1999 after 30 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Masimo SET® 2000 Pulse Oximeter and Accessories: named in the summary without a submission number

## Most influential descendants
- K050018: Teslaoxysat, Model Efoxysate (2005), 0 descendants of its own

## Indications for use
The Masimo SET*/Quartz 2500 Pulse Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation or arterial hemoglobin (SpO,) and pulse rate (measured by an SpO, sensor). The Masimo SET®/Quartz 2500 Pulse Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and home environments. The Masimo LNOP® Series of Sensors are indicated for the Masimo SET®/Quartz 2500 Pulse Oximeter and the following: A single use oximetry sensor intended for adults and pediatrics greater than 30kg. A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg; A single use oximetry sensor intended for neconates with good skin integrity Jess than 10kg; A single use oximetry sensor intended for neonates with poor skin integrity less than 1kg; and a reusable oximetry sensor intended for aduits apd pediatrics greater than 30kg. The Masimo PC Sedes of Patient Cables are indicated for use with the Masitno LNOP® Series of Sensors and the Masimo SET®/Quartz 2500 Pulse Oximeter.

Source page: https://510kreport.com/device/K993555
Methodology: https://510kreport.com/methodology