510(k) · Cleared
ClearedHaemonetics Cell Saver Elite Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corporation · CAC Apparatus, Autotransfusion
Cleared on May 24, 2016 as substantially equivalent to K120586 (Haemonetics Corp., 2012) after a 118-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- May 24, 2016
- Review
- 118 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932890 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK932890 Cell Saver 5 SystemHaemonetics Corp. · 1994 · Recalled
- 3 generations backK014083 Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. · 2002 · Recalled
- 2 generations backK101907 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 2010 · Recalled
- 1 generation backK120586 Cell Saver EliteHaemonetics Corp. · 2012
- This deviceK160197 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016
- Descendant · cites it directly · 1 of its ownK162423 Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK221722 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System…Haemonetics Corporation · 2022
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 |
|---|---|---|---|---|---|
| −4 | K932890 | Cell Saver 5 System | Haemonetics Corp. | 1994 | 13 |
| −3 | K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery System | Haemonetics Corp. | 2002 | 3 |
| −2 | K101907 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corp. | 2010 | 6 |
| −1 | K120586 | Cell Saver Elite | Haemonetics Corp. | 2012 | — |
| 0 (this device) | K160197 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | 2016 | — |
| +1 | K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | 2017 | — |
| +2 | K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Haemonetics Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K120586 | Cell Saver EliteSummary page 6…ansfusion system with fat washing protocol and modified 70mL bowl algorithm is substantially equivalent to the Cell Saver Elite Autotransufsion system cleared in K120586. The Cell Saver Elite is intended for use with the same hardware and disposables as the predicate device and in the same oper… | 2012 |
| † | K131553 | XTRA | 2014 |
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 |
|---|---|---|---|
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | 2017 | 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K162423 (Haemonetics Corporation, 2017) has gone furthest, with 1 descendant 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. 2016, 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 Haemonetics Cell Saver® Elite® Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.
The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160197: Haemonetics Cell Saver Elite Autotransfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160197
Report an extraction error
Are you the manufacturer?
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