# K223785: N9+

- Pathway: 510(k) (Traditional)
- Applicant: Nonagon, Ltd.
- Decided: Apr 14, 2023 after 119 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K952882 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202483: MyHomeDoc, Myhomedoc, Ltd. (2021) Summary page 4.
- K190242: Tyto Thermometer, Tyto Care, Ltd. (2019) Summary page 4.
- K181612: Tyto Stethoscope (OTC), Tyto Care, Ltd. (2018) Summary page 4.

## Indications for use
The N9+ (OTC) device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part. N9+ (OTC) device is intended for use by adult lay users in a non-clinical environment. Nonagon application enables counseling with the physician and transmission of the information over an IP network. The oxygen saturation (SpO2) sensor of the device is for Rx only.

Source page: https://510kreport.com/device/K223785
Methodology: https://510kreport.com/methodology