# K113214: Tlink Data Management System (DMS)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Feb 7, 2012 after 99 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941811 (1994). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012349: Metavision Clinical Information System, Imdsoft, Ltd. (2002) Summary page 1.

## Most influential descendants
- K131816: Sorin Connect Data Management System (2013), 2 descendants of its own
- K170460: Sorin Connect (2017), 1 descendant of its own
- K212003: ESSENZ Patient Monitor (2021), 0 descendants of its own

## Indications for use
The TLinkTM DMS is an electronic clinical record keeping and reporting system indicated for use in collecting, displaying, storing and managing data from external medical devices. The system facilitates the creation of electronic patient records and enables post-procedural case reviews. Data and records can be viewed on local workstations or transferred to a central computer or hospital network for storage and post-case analysis/reporting.

Source page: https://510kreport.com/device/K113214
Methodology: https://510kreport.com/methodology