510(k) · Cleared
ClearedShiley Therapeutic Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shiley, Inc. · CAC Apparatus, Autotransfusion
Cleared on Nov 27, 1991 after a 265-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Nov 27, 1991
- Review
- 265 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK910991 Shiley Therapeutic Autotransfusion SystemShiley, Inc. · 1991
- Descendant · cites it directly · 8 of its ownK982650 Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · Recalled
- Descendant · 2 generations on · 7 of its ownK020647 Dideco ElectaDideco S.P.A. · 2002 · Recalled
- Descendant · 3 generations on · 5 of its ownK101586 Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010
- Descendant · 4 generations on · 1 of its ownK112245 XTRASorin Group Italia S.R.L. · 2011
- Descendant · 4 generations on · 0 of its ownK241236 XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K982650Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · cites it directly8descendants
- K020647Dideco ElectaDideco S.P.A. · 2002 · 2 generations on7descendants
- K101586Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010 · 3 generations on5descendants
- K112245XTRASorin Group Italia S.R.L. · 2011 · 4 generations on1descendant
- K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910991 | Shiley Therapeutic Autotransfusion System | Shiley, Inc. | 1991 | — |
| +1 | K982650 | Autologous Blood Management System (Abms) | Dideco S.P.A. | 1998 | 2 |
| +2 | K020647 | Dideco Electa | Dideco S.P.A. | 2002 | 2 |
| +3 | K101586 | Xtra Autotransfusion System | Sorin Group Italia S.R.L. | 2010 | — |
| +4 | K112245 | XTRA | Sorin Group Italia S.R.L. | 2011 | — |
| +4 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982650 | Autologous Blood Management System (Abms) | 1998 | 8 |
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?
- Of its descendants, K982650 (Dideco S.P.A., 1998) has gone furthest, with 8 descendants of its own.
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 | — |
https://510kreport.com/device/K910991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910991: Shiley Therapeutic 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/K910991
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026