# K191403: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Dec 20, 2019 after 210 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: 9 generations back to K910772 (1991). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131021: Pulse Oximeter, Nonin Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K202743: Med-Link Temp-pulse Oximeter (2021), 0 descendants of its own

## Indications for use
The Nonin® Model 95910nyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%Sp0O2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. For %Sp02, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 — 1.0 inch (0.8 — 2.5 cm) thick, under non-motion conditions. For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 — 1.0 inch (0.8 — 2.5 cm) thick, under non-motion conditions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.

Source page: https://510kreport.com/device/K191403
Methodology: https://510kreport.com/methodology