# K020022: Dinamap Pro Series Monitor, Models 110, 210, 310, 410

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Feb 1, 2002 after 29 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962603 (1997). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992638: Dinamap Pro Series Monitor, Models 100, 200, 300, 400, Critikon Company, LLC (2000) Summary page 1.
- K992238: Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT, Lnop-Dci, Patient Cable (PC04, PC08, PC12), Masimo Corp. (1999) Summary page 2.
- K002248: Dinamap Pro 1000 Monitor, Model 1000, Critikon Company, LLC (2000) Summary page 2.

## 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 OCR of the scanned summary read 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 2.

## Most influential descendants
- K021435: Dinamap Pro Series Monitor, Models 110N,210N,310N,410N (2002), 0 descendants of its own

## Recalls of this device
- Apr 30, 2003 · Not classified · Z-0011-04: Reports of broken plug ground pins on AC power cords for patient monitors.

## Indications for use
The DINAMAP® Pro Series 110-410 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/K020022
Methodology: https://510kreport.com/methodology