# K132402: Sensmart Model X-100 Univeral Oximetry System

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Feb 21, 2014 after 204 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931154 (1993). 82 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 86 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113215: Model 7600 Regional Oximeter System with Equanox Technology, Nonin Medical, Inc. (2012) Summary page 1.
- K102715: Regional Oximeter, Nonin Medical, Inc. (2010) Summary page 9.
- K080255: Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter, Nonin Medical, Inc. (2008) Summary page 9.
- K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series, Nonin Medical, Inc. (2009) Summary page 1.
- K092678: Evision Data Management Software, Nonin Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K233827: OxiWear (2024), 0 descendants of its own
- K192900: H500 Multi-Sensing Oximetry System (2020), 0 descendants of its own

## Recalls of this device
- Nov 25, 2014 · Class II · Z-0901-2015: Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors wit

## Indications for use
Model X-100 Nonin's SenSmart' Model X-100O Universal Oximetry System isa modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6)channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors. The SenSmart system isintended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oxlmetry (SpO2) functionality Issuitable for use In both motion and non-motion conditions, Including patients who are well or poorly perfused. Model 81005(x) Nonin's Model B100S(X) reusable soft sensor isindicated for non-invasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions, It Is Intended for use Inenvironments including the operating room, surgical recovery, critical care, emergency room, tong-term care, and mobile environments. SenSmart Download Software The SenSmart Download Software isan optional accessory for use with Nonin's X-100M SenSmart Monitor only. It IsIntended for use by healthcare professionals when 1)transferring data from the X-lOOM to a computer Inorder to maintain Individual records of oximetry data, 2)reviewing data according to user-selected parameters, and 3)generating reports.

Source page: https://510kreport.com/device/K132402
Methodology: https://510kreport.com/methodology