# K223873: Boppli Infant Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Pyrames, Inc.
- Decided: Sep 29, 2023 after 280 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900247 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020537: TL10 Tensymeter Blood Pressure Monitoring System, Tensys Medical, Inc. (2002) Summary page 5.

## Recalls of this device
- Feb 24, 2025 · Class II · Z-1508-2025: Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 

## Indications for use
The Boppli Infant Blood Pressure Monitor is indicated for use by medically trained personnel in clinical settings, such as the NICU, PICU, CVICU, and emergency or operating room, to continuously monitor diastolic, systolic, and mean arterial blood pressures of neonates and infants, under 5 kilograms in weight, who have a palpable pulse.

Source page: https://510kreport.com/device/K223873
Methodology: https://510kreport.com/methodology