510(k) · Cleared
ClearedAutolog Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · CAC Apparatus, Autotransfusion
Cleared on Mar 22, 2010 as substantially equivalent to K982755 (Medtronic Blood Management, 1998) after a 126-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Mar 22, 2010
- Review
- 126 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972894 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972894 Autotransfusion Appartus (Autolog)Medtronic Blood Management · 1998 · Recalled
- 1 generation backK982755 Modification of Autotransfusion Apparatus (Autolog)Medtronic Blood Management · 1998
- This deviceK093535 Autolog Autotransfusion SystemMedtronic, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK181954 autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018
Most influential descendants
Showing 1 of 1 · See all- K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972894 | Autotransfusion Appartus (Autolog) | Medtronic Blood Management | 1998 | 1 |
| −1 | K982755 | Modification of Autotransfusion Apparatus (Autolog) | Medtronic Blood Management | 1998 | — |
| 0 (this device) | K093535 | Autolog Autotransfusion System | Medtronic, Inc. | 2010 | — |
| +1 | K181954 | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K982755 | Modification of Autotransfusion Apparatus (Autolog)Summary page 1…ansfusion Apparatus Regulation Number: 21 CFR 868.5830 Product Code: CAC Classification: Class 11 Predicate Devices autoLog® Autotransfusion System (K982755) Device Description The autoLog®D Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181954 | autoLog IQ Autotransfusion System | 2018 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181954 (Medtronic Perfusion Systems, 2018) has gone furthest, with 0 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. 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 autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not necessarily limited to, the following:
* General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical
* Postoperative treatment areas
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093535: Autolog 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/K093535
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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