# K022193: Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Aug 1, 2002 after 27 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 27 ancestors in all.
21 later devices descend from it; 1 cites it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014255: Dinamap Procare Series Monitor; Model 100, 200, 300, 400, Ge Medical Systems Information Technologies (2002)
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002)

## Cited in the summary but kept off the family tree
- K955846: Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount Thermometer, Y (1996). Our reading of the summary gave K955846, FDA’s number for Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus… (Y). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alaris Medical System”. Kept off the family tree. Summary page 3.

## Most influential descendants
- K073203: Carescape V100 (2007), 20 descendants of its own
- K102426: Carescape Model V100 Vital Signs Monitor (2010), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own
- K130584: Monitor B40 (2013), 8 descendants of its own
- K133576: Monitor B40 (2014), 7 descendants of its own

## Indications for use
The DINAMAPB ProCare Series 100N-400N Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. 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/K022193
Methodology: https://510kreport.com/methodology