# K982342: Dinamap MPS Select Portable Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Critikon Company, LLC
- Decided: Aug 14, 1998 after 39 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: 3 generations back to K896030 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971569: Dinamap MPS Portable Monitor, Johnson & Johnson Medical, Inc. (1997) Summary page 2.

## Indications for use
The DINAMAP MPS® Select® Portable Monitor is intended to monitor a single patient’s vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric and neonatal. The Portable Monitor networking capabilities are identical to the predicate device and include connection to the OBSERVER® Central Station via VHF, spread spectrum or hardwire communication; host communications for use on the auxiliary serial port or RS-232 serial port; and remote view protocol over Ethernet enabling communication with other devices such as currently-marketed DINAMAP® Monitors, remote display, data collection or hospital information system, or remote alarm. In addition, the Portable Monitor may be operated from internal NIMH batteries making the device portable. This device is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K982342
Methodology: https://510kreport.com/methodology