# K103584: Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda  Compatible Disposable and Reusable SPO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Envisen Industry Co. Limited
- Decided: Jun 10, 2011 after 185 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: 9 generations back to K941811 (1994). 74 ancestors in all.
No later device cites it as a predicate yet.
1 of 75 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K052186: Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-P, Nellcor Puritan Bennett, Inc. (2005) Summary page 1.
- K093853: Single-Patient Use Disposable Sensor Series, Nonin Medical, Inc. (2010) Summary page 1.
- K080255: Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter, Nonin Medical, Inc. (2008) Summary page 1.
- K062605: Philips SPO2 Reusable Sensor, Models M1196A and M1196T, Philips Medical Systems (2006) Summary page 1.
- K083705: Bci WW1020 Pulse Oximeter, Model WW1020, Smiths Medical Pm, Inc. (2009) Summary page 1.
- K910770: 504US Pulse Oximeter, Criticare Systems, Inc. (1991) Summary page 1.
- K962127: Ohmeda 3800 Pulse Oximeter, Ohmeda Medical (1996) Summary page 1.
- K010463: Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires, Datex-Ohmeda, Inc. (2001) Summary page 1.

## Indications for use
Envisen Disposable and Reusable Oximeter Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP0z) and pulse rate for patients in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K103584
Methodology: https://510kreport.com/methodology