# K092101: Reusable Pulse Oximeter Sensor, Model 8000 Series

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: Oct 21, 2009 after 99 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: 7 generations back to K910772 (1991). 34 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080255: Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter, Nonin Medical, Inc. (2008) Summary page 1.
- K063752: Lifesense, Model LS1-9R, Nonin Medical, Inc. (2007) Summary page 1.
- K040589: Modification to Avant 9600 Pulse Oximeter, Nonin Medical, Inc. (2004) Summary page 1.
- K052669: Avant Digital Pulse Oximetry System, Model 4000, 4100, Nonin Medical, Inc. (2005) Summary page 1.
- K050056: Model 2500A Palmsat Pulse Oximeter, Nonin Medical, Inc. (2005) Summary page 1.
- K002690: Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500, Nonin Medical, Inc. (2000) Summary page 1.
- K031487: Model Avant 2120 Pulse Oximeter and Nibp, Nonin Medical, Inc. (2004) Summary page 1.
- K992215: Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped, Envitec-Wismar GmbH (2000) Summary page 1.

## Most influential descendants
- 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
- 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
- K241728: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (2025), 0 descendants of its own
- K233827: OxiWear (2024), 0 descendants of its own

## Indications for use
Nonin's Model 8000SX Reusable Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments

Source page: https://510kreport.com/device/K092101
Methodology: https://510kreport.com/methodology