# K242962: Telemetry Monitor 5500 Release 4.0 (867232)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Böblingen GmbH
- Decided: May 5, 2025 after 222 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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: 30 generations back to K941811 (1994). 171 ancestors in all.
No later device cites it as a predicate yet.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180017: MX40 Release C.01, Philips Medical Systems (2018) Summary page 6.

## Recalls of this device
- Jun 5, 2026 · Class II · Z-2579-2026: Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitor

## Indications for use
Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

Source page: https://510kreport.com/device/K242962
Methodology: https://510kreport.com/methodology