# K201887: VS Newborn Heart Rate Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Surepulse Medical Limited
- Decided: Jul 23, 2021 after 380 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962603 (1997). 48 ancestors in all.
No later device cites it as a predicate yet.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter, Masimo Corporation (2009) Summary page 4.

## Recalls of this device
- Jan 20, 2023 · Class III · Z-1359-2026: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Jan 20, 2023 · Class III · Z-1358-2026: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Jan 20, 2023 · Class III · Z-1360-2026: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Jan 20, 2023 · Class III · Z-1357-2026: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Jan 20, 2023 · Class III · Z-1356-2026: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

## Indications for use
The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Source page: https://510kreport.com/device/K201887
Methodology: https://510kreport.com/methodology