510(k) · Cleared
ClearedTlink Data Management System (DMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Feb 7, 2012 as substantially equivalent to K012349 (Imdsoft, Ltd., 2002) after a 99-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- Feb 7, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941811 (1994). 16 ancestors in all, the oldest K822695 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 2 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 1 generation backK012349 Metavision Clinical Information SystemImdsoft, Ltd. · 2002
- This deviceK113214 Tlink Data Management System (DMS)Terumo Cardiovascular Systems Corp. · 2012
- Descendant · cites it directly · 2 of its ownK131816 Sorin Connect Data Management SystemSorin Group Deutschland GmbH · 2013
- Descendant · 2 generations on · 1 of its ownK170460 Sorin ConnectSorin Group Deutschland GmbH · 2017
- Descendant · 3 generations on · 0 of its ownK212003 ESSENZ Patient MonitorLivanova Deutschland, GmbH · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −5 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −4 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −3 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −2 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −1 | K012349 | Metavision Clinical Information System | Imdsoft, Ltd. | 2002 | — |
| 0 (this device) | K113214 | Tlink Data Management System (DMS) | Terumo Cardiovascular Systems Corp. | 2012 | — |
| +1 | K131816 | Sorin Connect Data Management System | Sorin Group Deutschland GmbH | 2013 | — |
| +2 | K170460 | Sorin Connect | Sorin Group Deutschland GmbH | 2017 | — |
| +3 | K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012349 | Metavision Clinical Information SystemSummary page 1…ardiovascular Regulation 870.2450 Medical Cathode-ray tube display Product Codle(s) DXJ Legally marketed K012349, MetaVision Clinical Information System device(s) to which equivalence is claimed Reason for 51 0(k) Traditional 510(k)… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131816 | Sorin Connect Data Management System | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K131816 (Sorin Group Deutschland GmbH, 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K012349.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113214: Tlink Data Management System (DMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113214
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026