# 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 - Pathway: 510(k) (Traditional) - Applicant: Nonin Medical, Inc. - Decided: Aug 5, 2016 after 128 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: 13 generations back to K931154 (1993). 83 ancestors in all. 1 later device descends from it; 1 cites it directly. 1 of 85 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K132402: Sensmart Model X-100 Univeral Oximetry System, Nonin Medical, Inc. (2014) Summary page 8. - K080255: Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter, Nonin Medical, Inc. (2008) Summary page 8. ## Cited in the summary but kept off the family tree - K090853: Yield Tissue Sampler, Broncus Technologies, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K233827: OxiWear (2024), 0 descendants of its own ## Indications for use Nonin’s Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 lb; 6100CP: pediatrics > 10 kg / 22 lb.; 6100CI: infants > 2 kg / 4 lb; and 6100CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. Nonin’s Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 lb.; 6101CI: infants > 2 kg / 4 lb; and 6101CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. Nonin’s Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 lb; 6102CP: pediatrics > 10 kg / 22 lb.; 6102CI: infants > 2 kg / 4 lb; and 6102CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The Model 8100Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The recommended application site is the earlobe. The Model 8101Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The recommended application site is the earlobe. The Model 8102Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The recommended application site is the earlobe. Source page: https://510kreport.com/device/K160865 Methodology: https://510kreport.com/methodology