# K971569: Dinamap MPS Portable Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Sep 19, 1997 after 143 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: 2 generations back to K896030 (1989). 10 ancestors in all.
43 later devices descend from it; 3 cite it directly.
1 of 54 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955113: Dinamap Select Multi-Parameter System, Johnson & Johnson Medical, Inc. (1996) Summary page 2.

## Most influential descendants
- K992638: Dinamap Pro Series Monitor, Models 100, 200, 300, 400 (2000), 40 descendants of its own
- K014255: Dinamap Procare Series Monitor; Model 100, 200, 300, 400 (2002), 22 descendants of its own
- K022193: Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N (2002), 21 descendants of its own
- K073203: Carescape V100 (2007), 20 descendants of its own
- K063055: VS-800 Vital Signs Monitor (2006), 13 descendants of its own

## 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 (K955113) 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/K971569
Methodology: https://510kreport.com/methodology