510(k) · Cleared
ClearedSorin Connect Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Jul 23, 2013 as substantially equivalent to K100272 (Philips Medical Systems, 2010) and 1 other predicate after a 33-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 23, 2013
- Review
- 33 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K941811 (1994). 18 ancestors in all, the oldest K822695 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 3 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 2 generations backK012349 Metavision Clinical Information SystemImdsoft, Ltd. · 2002
- 1 generation backK113214 Tlink Data Management System (DMS)Terumo Cardiovascular Systems Corp. · 2012
- This deviceK131816 Sorin Connect Data Management SystemSorin Group Deutschland GmbH · 2013
- Descendant · cites it directly · 1 of its ownK170460 Sorin ConnectSorin Group Deutschland GmbH · 2017
- Descendant · 2 generations on · 0 of its ownK212003 ESSENZ Patient MonitorLivanova Deutschland, GmbH · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −6 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −5 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −4 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −3 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −2 | K012349 | Metavision Clinical Information System | Imdsoft, Ltd. | 2002 | — |
| −1 | K113214 | Tlink Data Management System (DMS) | Terumo Cardiovascular Systems Corp. | 2012 | — |
| 0 (this device) | K131816 | Sorin Connect Data Management System | Sorin Group Deutschland GmbH | 2013 | — |
| +1 | K170460 | Sorin Connect | Sorin Group Deutschland GmbH | 2017 | — |
| +2 | 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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K100272 | Intellivue Clinical Information PortfolioSummary page 1…Data Management System CLASSIFICATION NAME: Display, Cathode-ray Tube, Medical PREDICATE DEVICE: IntelliVue Clinical Information Portfolio K100272 TLink Data Mangement System K1 13214 DEVICE DESCRIPTION: The Sorin CONNECT is… | 2010 |
| * | K113214 | Tlink Data Management System (DMS)Summary page 1…Medical PREDICATE DEVICE: IntelliVue Clinical Information Portfolio K100272 TLink Data Mangement System K1 13214 DEVICE DESCRIPTION: The Sorin CONNECT is aiming to capture, display and store numerical or other perfusion related information… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170460 | Sorin Connect | 2017 | 1 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K170460 (Sorin Group Deutschland GmbH, 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K100272.
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. 2013, 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?
Sorin CONNECT is a modularly structured program package that is exclusively used
With Sorin/Stöckert heart lung machines. The system allows detailed recording of
perfusion data during cardiopulmonary bypass as well as the processing and
evaluation of this data. The data may be recorded automatically or entered manually.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131816: Sorin Connect Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131816
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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