# K970182: Dinamap Compact Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Aug 18, 1997 after 213 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913695 (1991). 4 ancestors in all.
41 later devices descend from it; 1 cites it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943709: Dinamap Plus Vital Signs Monoitor, Critikon Company, LLC (1995) Summary page 2.
- K912188: Dinamap Plus Physiological Monitor Model 8700, Critikon Company, LLC (1991) Summary page 2.
- K942700: Dinamap Vital Signs Monitor Models 9300 and 9320/9340, Critikon Company, LLC (1995) Summary page 2.
- K913695: Nellcor (R) N-180 Pulse Oximeter, Nellcor, Inc. (1991) 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 Compact Monitor is intended to monitor a single adult, pediatric or neonatal patient’s vital signs at the bedside. Vital signs parameters include noninvasive blood pressure (systolic, diastolic and mean arterial pressure), pulse rate, temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings, primarily in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor & delivery, endoscopy, cardiac step-down, etc. and can also be used during many specialized procedures in satellite areas, or in ambulatory surgery centers, physicians’ offices or alternate care settings.

Source page: https://510kreport.com/device/K970182
Methodology: https://510kreport.com/methodology