# K972829: Cricket 2000 Recording Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Oct 28, 1997 after 90 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: 1 generation back to K914085 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935510: VX4 Recording Pulse Oximeter, Vitalog Monitoring,Inc. (1994) Summary page 1.
- K914620: HMS-4000 Physiological Monitor, Modification, Vitalog Monitoring,Inc. (1992) Summary page 1.
- K914085: HMS-5000, Vitalog Monitoring,Inc. (1991) Summary page 1.

## Indications for use
The Cricket 2000 is a recording pulse oximeter which measures functional blood oxygen saturation, pulse rate/interval and finger movement. Because of SpO2 and pulse rate alarm limits that can be set by the operator, it can be used for continuous monitoring. It also interfaces with a commercially available computer. The pulse oximetry, raw infrared and red waveform data, as well as the pulse rate data, can be viewed real-time on the computer using custom Windows®-based software that is provided with the pulse oximeter. The software also enables the user to do some data analysis, which can be used to draw meaningful implications during sleep apnea analysis studies. The Cricket 2000 is primarily indicated for use with patients suspected of suffering from, or with potential to suffer from, episodes of hypoxemia. The Cricket 2000 is intended for patients weighing more than 30 kg in both the hospital/institutional environment (supervised) and the home (unsupervised) environment.

Source page: https://510kreport.com/device/K972829
Methodology: https://510kreport.com/methodology