# K231620: Nuubo Smart

- Pathway: 510(k) (Traditional)
- Applicant: Smart Solutions Technologies SL
- Decided: Aug 1, 2023 after 60 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K882803 (1988). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173461: ECG recorder and Arrhythmia Detector, Smart Solutions Technologies SL (2018) Summary page 4.
- K133701: Nuvant MCT System, Corventis, Inc. (2014) Summary page 4.

## Indications for use
The Nuubo Smart is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The Nuubo Smart continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo Smart detects arrhythmias at the end of each monitoring day upon download of the ECG data. The Nuubo Smart is Rx use device.

Source page: https://510kreport.com/device/K231620
Methodology: https://510kreport.com/methodology