# K992638: Dinamap Pro Series Monitor, Models 100, 200, 300, 400

- Pathway: 510(k) (Traditional)
- Applicant: Critikon Company, LLC
- Decided: Feb 24, 2000 after 202 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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). 13 ancestors in all.
40 later devices descend from it; 4 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 1.
- K971569: Dinamap MPS Portable Monitor, Johnson & Johnson Medical, Inc. (1997) Summary page 1.
- K970182: Dinamap Compact Monitor, Johnson & Johnson Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K102426: Carescape Model V100 Vital Signs Monitor (2010), 11 descendants of its own

## Indications for use
The DINAMAP® Pro Series 100, 200, 300, 400 Monitor is intended to monitor a single adult, pediatric or neonatal patient’s vital signs. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians’ offices, or alternate care settings.

Source page: https://510kreport.com/device/K992638
Methodology: https://510kreport.com/methodology