510(k) · Cleared
ClearedXtra Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · CAC Apparatus, Autotransfusion
Cleared on Oct 5, 2010 as substantially equivalent to K020647 (Dideco S.P.A., 2002) after a 120-day review. Its family tree reaches back 3 generations to 1989. 5 later devices descend from it.
- Decided
- Oct 5, 2010
- Review
- 120 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884564 (1989). 8 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK884564 Shiley Therapeutic Autotransfusion System-ProgrammShiley, Inc. · 1989
- 2 generations backK982650 Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · Recalled
- 1 generation backK020647 Dideco ElectaDideco S.P.A. · 2002 · Recalled
- This deviceK101586 Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010
- Descendant · cites it directly · 1 of its ownK112245 XTRASorin Group Italia S.R.L. · 2011
- Descendant · cites it directly · 0 of its ownK241236 XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
- Descendant · cites it directly · 0 of its ownK240584 XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024
- Descendant · 2 generations on · 0 of its ownK131553 XTRASorin Group Deutschland GmbH · 2014
- Descendant · cites it directly · 0 of its ownK103202 Preassembled Surgical Wash SetSorin Group Italia S.R.L. · 2010
Most influential descendants
Showing 5 of 5 · See all- K112245XTRASorin Group Italia S.R.L. · 2011 · cites it directly1descendant
- K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024 · cites it directly0descendants
- K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024 · cites it directly0descendants
- K131553XTRASorin Group Deutschland GmbH · 2014 · 2 generations on0descendants
- K103202Preassembled Surgical Wash SetSorin Group Italia S.R.L. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884564 | Shiley Therapeutic Autotransfusion System-Programm | Shiley, Inc. | 1989 | — |
| −2 | K982650 | Autologous Blood Management System (Abms) | Dideco S.P.A. | 1998 | 2 |
| −1 | K020647 | Dideco Electa | Dideco S.P.A. | 2002 | 2 |
| 0 (this device) | K101586 | Xtra Autotransfusion System | Sorin Group Italia S.R.L. | 2010 | — |
| +1 | K112245 | XTRA | Sorin Group Italia S.R.L. | 2011 | — |
| +1 | K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | 2024 | — |
| +1 | K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | 2024 | — |
| +2 | K131553 | XTRA | Sorin Group Deutschland GmbH | 2014 | — |
| +1 | K103202 | Preassembled Surgical Wash Set | Sorin Group Italia S.R.L. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 2 | 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 CAC? 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 CAC device
- #1 K240426 Aventus Clot Management Systemscore 11.2 · 4 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 |
|---|---|---|---|
| * | K020647 | Dideco ElectaSummary page 1…Autotransfusion System CLASSIFICATION NAME: Apparatus, Autotransfusion PREDICATE DEVICE: Dideco ELECTA K(020647 DEVICE DESCRIPTION: XTRA Autotransfusion System consists of hardware and disposables. It is the next generation of the Sorin aut… | 2002 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K112245 (Sorin Group Italia S.R.L., 2011) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K020647.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CAC
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAC
91in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAC
7in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CAC
128in 2025
MAUDE reports naming product code CAC, 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 | 0 | — | 1 | 35 |
| 2008 | 1 | — | 5 | 12 |
| 2009 | 0 | — | 25 | 68 |
| 2010 | 4 | 123 | 3 | 115 |
| 2011 | 2 | — | 3 | 939 |
| 2012 | 3 | 90 | 0 | 249 |
| 2013 | 1 | — | 9 | 153 |
| 2014 | 3 | 269 | 0 | 90 |
| 2015 | 0 | — | 0 | 87 |
| 2016 | 2 | — | 0 | 73 |
| 2017 | 1 | — | 2 | 88 |
| 2018 | 2 | — | 2 | 87 |
| 2019 | 1 | — | 23 | 64 |
| 2020 | 1 | — | 0 | 108 |
| 2021 | 4 | 155 | 0 | 73 |
| 2022 | 1 | — | 0 | 65 |
| 2023 | 2 | — | 7 (2) | 39 |
| 2024 | 3 | 91 | 0 | 129 |
| 2025 | 0 | — | 0 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The XTRA Autotransfusion System is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:
- Cardiovascular
- Orthopedics
- Thoracic
- Transplant Surgery
- Emergency (Trauma)
- Neurosurgery
- Obstetrics and gynecology
- Urology
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101586: Xtra Autotransfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101586
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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