510(k) · Cleared
Recalled · Class II · 2019Haemonetics Cell Saver Elite Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · CAC Apparatus, Autotransfusion
Cleared on Dec 3, 2010 as substantially equivalent to K014083 (Haemonetics Corp., 2002) after a 148-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 3, 2010
- Review
- 148 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932890 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK932890 Cell Saver 5 SystemHaemonetics Corp. · 1994 · Recalled
- 1 generation backK014083 Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. · 2002 · Recalled
- This deviceK101907 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 2010
- Descendant · cites it directly · 3 of its ownK120586 Cell Saver EliteHaemonetics Corp. · 2012
- Descendant · 2 generations on · 2 of its ownK160197 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016
- Descendant · 3 generations on · 1 of its ownK162423 Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017
- Descendant · 4 generations on · 0 of its ownK221722 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System…Haemonetics Corporation · 2022
Most influential descendants
Showing 4 of 4 · See all- K120586Cell Saver EliteHaemonetics Corp. · 2012 · cites it directly3descendants
- K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016 · 2 generations on2descendants
- K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017 · 3 generations on1descendant
- K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932890 | Cell Saver 5 System | Haemonetics Corp. | 1994 | 13 |
| −1 | K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery System | Haemonetics Corp. | 2002 | 3 |
| 0 (this device) | K101907 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corp. | 2010 | — |
| +1 | K120586 | Cell Saver Elite | Haemonetics Corp. | 2012 | — |
| +2 | K160197 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | 2016 | — |
| +3 | K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | 2017 | — |
| +4 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery SystemSummary page 1…ver Elite Autotransfusion System is an evolution of the Haemonetics Cell SaverS5 Autologous Blood Recovery System. The Cell Savers5 was most recently cleared via 5 10(k) K014083. The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia tec… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120586 | Cell Saver Elite | 2012 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2019 | Class II | Z-0895-2020 | Device Design | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the… |
| Oct 21, 2019 | Class II | Z-0892-2020 | Device Design | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the… |
| Oct 21, 2019 | Class II | Z-0893-2020 | Device Design | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the… |
| Oct 21, 2019 | Class II | Z-0894-2020 | Device Design | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the… |
| Oct 21, 2019 | Class II | Z-0896-2020 | Device Design | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the… |
| Aug 2, 2017 | Class II | Z-0779-2019 | Process control | Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 8.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K120586 (Haemonetics Corp., 2012) has gone furthest, with 3 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 Haemonetics Cell Saver® EliteTM 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/K101907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101907: 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/K101907
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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