510(k) · Cleared
ClearedXres Blood Collection Reservoir Xres 120MICROMETER Blood Collection Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Jun 6, 2013 as substantially equivalent to K100507 (Sorin Group Italia S.R.L., 2010) after a 48-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.
- Decided
- Jun 6, 2013
- Review
- 48 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100507 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK100507 Xres Blood Collection ReservoirSorin Group Italia S.R.L. · 2010
- This deviceK131103 Xres Blood Collection Reservoir Xres 120MICROMETER Blood Collection…Sorin Group Italia S.R.L. · 2013
- Descendant · cites it directly · 0 of its ownK241236 XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100507 | Xres Blood Collection Reservoir | Sorin Group Italia S.R.L. | 2010 | — |
| 0 (this device) | K131103 | Xres Blood Collection Reservoir Xres 120MICROMETER Blood Collection Reservoir | Sorin Group Italia S.R.L. | 2013 | — |
| +1 | K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 DTN? 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 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 |
|---|---|---|---|
| * | K100507 | Xres Blood Collection ReservoirSummary page 1…ction Reservoir COMMON NAME: Blood Collection Reservoir CLASSIFICATION NAME: Cardiopulmonary Bypass Blood Reservoir . UNMODIFIED DEVICE: XRES Blood Collection Reservoir (K100507) DEVICE DESCRIPTION: The XRES and XRES 120pm Blood Collection Reservoirs are modified versions of the currently marketed XRES r… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set X | 2024 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K241236 (Sorin Group Italia S.R.L., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion
The device is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131103: Xres Blood Collection Reservoir Xres 120MICROMETER Blood Collection Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131103
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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