# K241397: Hinscope

- Pathway: 510(k) (Traditional)
- Applicant: Hinlab Sas
- Decided: Nov 14, 2024 after 182 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 38 generations back to K941811 (1994). 355 ancestors in all.
No later device cites it as a predicate yet.
2 of 356 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191272: Wearable Device, Wearable Package, Current Health, Ltd. (2019) Summary page 7.

## Indications for use
Hinscope is intended for spot-check vital signs measurement of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities. It is intended to be used by trained healthcare professionals. Hinscope is intended for spot-check measurements, in adults, of: ● Non-Invasive Blood Pressure (NIBP) ● Pulse rate (PR) ● Oxygen saturation (SpO2) Hinscope is not intended for use in high-acuity environments, such as intensive care units (ICU) or operating rooms. Hinscope is not intended for use on acutely ill cardiac patients with the potential to develop life-threatening arrhythmias e.g. very fast atrial fibrillation. These patients should be monitored using a device with continuous electrocardiogram (ECG). Hinscope is not a substitute for an ECG monitor. Hinscope is not intended for SpO2 and PR measurements in conditions of high motion or low perfusion.

Source page: https://510kreport.com/device/K241397
Methodology: https://510kreport.com/methodology