# K982969: Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Aug 12, 1999 after 352 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950387 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893221: Model 8500 Hand Held Pulse Oximeter, Nonin Medical, Inc. (1990) Summary page 1.
- K945290: 8500A Pulse Oximeter, Nonin Medical, Inc. (1997) Summary page 1.
- K915494: Nellcor Stat-Cap Airway CO2 Indicator, Model N-60, Nellcor, Inc. (1993) Summary page 1.
- K964239: Combination Oximeter/Carbon Dioxide Gas Analyzer, Spegas Industries, Ltd. (1997) Summary page 1.

## Indications for use
The NONIN® Pulse Oximeter and Carbon Dioxide Detector (Model 9840-Series) is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate, and approximate carbon dioxide (CO₂) changes in the airway of intubated patients. These functions may be used separately or simultaneously.

Source page: https://510kreport.com/device/K982969
Methodology: https://510kreport.com/methodology