510(k) · Cleared
Recalled · Class II · 2017Haemonetics Cell Saver 5 Autologous Blood Recovery 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 Jan 8, 2002 as substantially equivalent to K932890 (Haemonetics Corp., 1994) after a 28-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 8, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932890 (1994). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK932890 Cell Saver 5 SystemHaemonetics Corp. · 1994 · Recalled
- This deviceK014083 Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. · 2002
- Descendant · cites it directly · 4 of its ownK101907 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK120586 Cell Saver EliteHaemonetics Corp. · 2012
- Descendant · 3 generations on · 2 of its ownK160197 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016
- Descendant · 4 generations on · 1 of its ownK162423 Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017
- Descendant · 5 generations on · 0 of its ownK221722 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System…Haemonetics Corporation · 2022
Most influential descendants
Showing 5 of 5 · See all- K101907Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 2010 · cites it directly4descendants
- K120586Cell Saver EliteHaemonetics Corp. · 2012 · 2 generations on3descendants
- K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016 · 3 generations on2descendants
- K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017 · 4 generations on1descendant
- K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932890 | Cell Saver 5 System | Haemonetics Corp. | 1994 | 13 |
| 0 (this device) | K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery System | Haemonetics Corp. | 2002 | — |
| +1 | K101907 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corp. | 2010 | 6 |
| +2 | K120586 | Cell Saver Elite | Haemonetics Corp. | 2012 | — |
| +3 | K160197 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | 2016 | — |
| +4 | K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | 2017 | — |
| +5 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K932890 | Cell Saver 5 SystemSummary page 1…mL bowl) ¢ LN263 Haemonetics Basic High Speed Cell Saver 5 Bowl Set (225mL bowl) List No Predicate Device Reference CS5 with Cell Salvage and CS5 with Cell Salvage and K932890 Sequestration Protocol Sequestration Protocol Software Software Revision K Revision - e LN261 Haemonetics Basic Low e K932890 LN… | 1994 |
| * | — | LN246 10L Waste Bag Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101907 | Haemonetics Cell Saver Elite Autotransfusion System | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2017 | Class II | Z-0778-2019 | Process control | Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. |
| Dec 21, 2005 | Not classified | Z-0822-06 | Other | Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard |
| Dec 21, 2005 | Not classified | Z-0823-06 | Other | Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K101907 (Haemonetics Corp., 2010) has gone furthest, with 4 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.
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 Cell Saver 5 Autologous Blood Recovery System is 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…
Read the full statement (133 words)
The Cell Saver 5 Autologous Blood Recovery System is 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.
The LN291A is intended to be used with the CS5 Autologous Blood Recovery System for cell salvage protocols.
The LN242 is intended to be used with the CS5 Autologous Blood Recovery System as a replacement waste bag.
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/K014083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014083: Haemonetics Cell Saver 5 Autologous Blood Recovery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014083
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026