510(k) · Cleared
ClearedModification of Autotransfusion Apparatus (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 Aug 20, 1998 as substantially equivalent to K972894 (Medtronic Blood Management, 1998) after a 52-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Aug 20, 1998
- Review
- 52 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972894 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972894 Autotransfusion Appartus (Autolog)Medtronic Blood Management · 1998 · Recalled
- This deviceK982755 Modification of Autotransfusion Apparatus (Autolog)Medtronic Blood Management · 1998
- Descendant · cites it directly · 1 of its ownK093535 Autolog Autotransfusion SystemMedtronic, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK181954 autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972894 | Autotransfusion Appartus (Autolog) | Medtronic Blood Management | 1998 | 1 |
| 0 (this device) | K982755 | Modification of Autotransfusion Apparatus (Autolog) | Medtronic Blood Management | 1998 | — |
| +1 | K093535 | Autolog Autotransfusion System | Medtronic, Inc. | 2010 | — |
| +2 | K181954 | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K972894 | Autotransfusion Appartus (Autolog)Summary page 1…usion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.” The description of the device remains the same as 510k # K972894. “The autoLog Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system is a centrifugal uni… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093535 | Autolog Autotransfusion System | 2010 | 1 |
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?
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/K982755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982755: Modification of Autotransfusion Apparatus (Autolog).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982755
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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