510(k) · Cleared
ClearedHaemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corporation · CAC Apparatus, Autotransfusion
Cleared on Nov 15, 2022 as substantially equivalent to K162423 (Haemonetics Corporation, 2017) after a 154-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Nov 15, 2022
- Review
- 154 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932890 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK932890 Cell Saver 5 SystemHaemonetics Corp. · 1994 · Recalled
- 5 generations backK014083 Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. · 2002 · Recalled
- 4 generations backK101907 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 2010 · Recalled
- 3 generations backK120586 Cell Saver EliteHaemonetics Corp. · 2012
- 2 generations backK160197 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016
- 1 generation backK162423 Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017
- This deviceK221722 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System…Haemonetics Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932890 | Cell Saver 5 System | Haemonetics Corp. | 1994 | 13 |
| −5 | K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery System | Haemonetics Corp. | 2002 | 3 |
| −4 | K101907 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corp. | 2010 | 6 |
| −3 | K120586 | Cell Saver Elite | Haemonetics Corp. | 2012 | — |
| −2 | K160197 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | 2016 | — |
| −1 | K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | 2017 | — |
| 0 (this device) | K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Haemonetics Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemSummary page 4…transfusion Device Classification Name: Autotransfusion Apparatus Regulation Number: 21 CFR 868.5830 Product Code: CAC Device Class: 2 510k Number: K162423 Reference Device Information: Trade Name: Medtronic autoLog IQ Autotransfusion System Common Name: Autotransfus… | 2017 |
| † | K181954 | autoLog IQ Autotransfusion System | 2018 |
| † | K131553 | XTRA | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/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 the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within the recommended time guidelines of the American Association of Blood Banks (AABB), 9th Edition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221722: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221722
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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