# K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package

- Pathway: 510(k) (Traditional)
- Applicant: Snap40, Ltd.
- Decided: Nov 14, 2018 after 58 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: 35 generations back to K941811 (1994). 312 ancestors in all.
19 later devices descend from it; 1 cites it directly.
2 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set, Draeger Medical Systems, Inc. (2012) Summary page 6.
- K151860: Infinity CentralStation Wide, Draeger Medical Systems, Inc. (2015) Summary page 6.
- K132320: Intellivue CL Respiration Pod, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2014) Summary page 6.
- K161767: Philips IntelliVue GuardianSoftware, Philips Medizin Systeme Boeblingen GmbH (2017) Summary page 6.

## Most influential descendants
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (2019), 18 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own

## Indications for use
snap40 is intended for reusable bedside, mobile and central multi-parameter, continuous and intermittent physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals. snap40 is intended to provide visual and audible physiologic multi-parameter alarms. snap40 is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. snap40 continuously monitors the following parameters in adults: • Pulse rate • Oxygen saturation • Temperature • Movement snap40 is intended for intermittent or spot-check monitoring of respiration rate. snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor. snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

Source page: https://510kreport.com/device/K182543
Methodology: https://510kreport.com/methodology