510(k) · Cleared
Recalled · 2010Autotransfusion Appartus (Autolog)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Blood Management · CAC Apparatus, Autotransfusion
Cleared on Apr 27, 1998 after a 265-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 27, 1998
- Review
- 265 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK972894 Autotransfusion Appartus (Autolog)Medtronic Blood Management · 1998
- Descendant · cites it directly · 2 of its ownK982755 Modification of Autotransfusion Apparatus (Autolog)Medtronic Blood Management · 1998
- Descendant · 2 generations on · 1 of its ownK093535 Autolog Autotransfusion SystemMedtronic, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK181954 autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018
- Descendant · cites it directly · 0 of its ownK060482 Cytori Celution Cell Concentration DeviceCytori Therapeutics, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K982755Modification of Autotransfusion Apparatus (Autolog)Medtronic Blood Management · 1998 · cites it directly2descendants
- K093535Autolog Autotransfusion SystemMedtronic, Inc. · 2010 · 2 generations on1descendant
- K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018 · 3 generations on0descendants
- K060482Cytori Celution Cell Concentration DeviceCytori Therapeutics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972894 | Autotransfusion Appartus (Autolog) | Medtronic Blood Management | 1998 | — |
| +1 | K982755 | Modification of Autotransfusion Apparatus (Autolog) | Medtronic Blood Management | 1998 | — |
| +2 | K093535 | Autolog Autotransfusion System | Medtronic, Inc. | 2010 | — |
| +3 | K181954 | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | 2018 | — |
| +1 | K060482 | Cytori Celution Cell Concentration Device | Cytori Therapeutics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | — | Sequestra Named without a submission number | |
| * | — | ELMD 500 autotransfusion apparatus Named without a submission number |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Apr 21, 2010 | Not classified | Z-1939-2010 | Nonconforming Material/Component | The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982755 (Medtronic Blood Management, 1998) has gone furthest, with 2 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 | — |
What is it indicated for?
The autoLog™ is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following:
General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical
Postoperative treatment areas
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/K972894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972894: Autotransfusion Appartus (Autolog).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972894
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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