510(k) · Cleared
Recalled · 2006Dideco Electa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.P.A. · CAC Apparatus, Autotransfusion
Cleared on Sep 5, 2002 as substantially equivalent to K982650 (Dideco S.P.A., 1998) and 1 other predicate after a 189-day review. Its family tree reaches back 2 generations to 1989. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 5, 2002
- Review
- 189 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884564 (1989). 7 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK884564 Shiley Therapeutic Autotransfusion System-ProgrammShiley, Inc. · 1989
- 1 generation backK982650 Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · Recalled
- This deviceK020647 Dideco ElectaDideco S.P.A. · 2002
- Descendant · cites it directly · 5 of its ownK101586 Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010
- Descendant · 2 generations on · 1 of its ownK112245 XTRASorin Group Italia S.R.L. · 2011
- Descendant · 2 generations on · 0 of its ownK241236 XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
- Descendant · 2 generations on · 0 of its ownK240584 XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024
- Descendant · 3 generations on · 0 of its ownK131553 XTRASorin Group Deutschland GmbH · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101586Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010 · cites it directly5descendants
- K112245XTRASorin Group Italia S.R.L. · 2011 · 2 generations on1descendant
- K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024 · 2 generations on0descendants
- K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024 · 2 generations on0descendants
- K131553XTRASorin Group Deutschland GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884564 | Shiley Therapeutic Autotransfusion System-Programm | Shiley, Inc. | 1989 | — |
| −1 | K982650 | Autologous Blood Management System (Abms) | Dideco S.P.A. | 1998 | 2 |
| 0 (this device) | K020647 | Dideco Electa | Dideco S.P.A. | 2002 | — |
| +1 | K101586 | Xtra Autotransfusion System | Sorin Group Italia S.R.L. | 2010 | — |
| +2 | K112245 | XTRA | Sorin Group Italia S.R.L. | 2011 | — |
| +2 | K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | 2024 | — |
| +2 | K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | 2024 | — |
| +3 | K131553 | XTRA | Sorin Group Deutschland GmbH | 2014 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 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? (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 |
|---|---|---|---|
| * | K982650 | Autologous Blood Management System (Abms)Summary page 1…Autotransfusion Device Classification Names: Autotransfusion Apparatus 3. PREDICATE DEVICES 0 Dideco ABMS K982650 e Cobe Brat I1 K99 1986 4. INTENDED USE The Dideco electa is indicated for intraoperative an… | 1998 |
| * | K991986 | Cobe Brat 2 Autologous Blood Salvage System with the Crit-Line Hematocrit Sampling…Summary page 1…assification Names: Autotransfusion Apparatus 3. PREDICATE DEVICES 0 Dideco ABMS K982650 e Cobe Brat I1 K99 1986 4. INTENDED USE The Dideco electa is indicated for intraoperative and postoperative recovery of blood… | 1999 |
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2006 | Not classified | Z-1491-06 | Other | Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood. |
| Aug 4, 2006 | Not classified | Z-1489-06 | Other | Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K101586 (Sorin Group Italia S.R.L., 2010) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K982650.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Dideco electa is indicated for intraoperative recovery of blood, washng of blood collected in the post-operative period, and preKoperative sequestration (with indirect and direct 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/K020647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020647: Dideco Electa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020647
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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