# K063752: Lifesense, Model LS1-9R

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: May 4, 2007 after 136 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: 3 generations back to K950387 (1995). 4 ancestors in all.
12 later devices descend from it; 3 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024300: Microcap Plus/NPB-75, Oridion Medical 1987, Ltd. (2003) Summary page 1.
- K970209: Capnocheck Plus, Bci Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series (2009), 7 descendants of its own
- K132402: Sensmart Model X-100 Univeral Oximetry System (2014), 3 descendants of its own
- K172586: Vios Monitoring System™ Model 2050 (2018), 2 descendants of its own
- K093853: Single-Patient Use Disposable Sensor Series (2010), 2 descendants of its own
- K160865: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso (2016), 1 descendant of its own

## Indications for use
The LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC0 2), respiration and pulse rate of well or poorly perfused adult, pediatric and infant patients. It is intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, e.g. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.

Source page: https://510kreport.com/device/K063752
Methodology: https://510kreport.com/methodology