# K913695: Nellcor (R) N-180 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor, Inc.
- Decided: Nov 13, 1991 after 86 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
No predicates in its family tree.
199 later devices descend from it; 6 cite it directly.
1 of 200 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K952912: Spacelabs Medical Integrated Multi-Parameter Module (1997), 150 descendants of its own
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496 (1998), 149 descendants of its own
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX (2000), 119 descendants of its own
- K032733: PM-8000 Patient Monitor, Model 8000 (2004), 88 descendants of its own
- K043348: Modification to PM-8000 Patient Monitor (2005), 87 descendants of its own

Source page: https://510kreport.com/device/K913695
Methodology: https://510kreport.com/methodology