510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Cell Saver 5 System

K932890510(k) TraditionalCleared Jan 5, 1994205-day reviewClass II21 CFR 868.5830Recalls 13

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Haemonetics Corp. · CAC Apparatus, Autotransfusion

Cleared on Jan 5, 1994 after a 205-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 13 times.

Decided
Jan 5, 1994
Review
205 days
Class
Class II
Product code
CAC
Recalls
13
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK932890 Cell Saver 5 SystemHaemonetics Corp. · 1994
  2. Descendant · cites it directly · 5 of its ownK014083 Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. · 2002 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK101907 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 2010 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK120586 Cell Saver EliteHaemonetics Corp. · 2012
  5. Descendant · 4 generations on · 2 of its ownK160197 Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016
  6. Descendant · 5 generations on · 1 of its ownK162423 Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12010: 12012: 12016: 12017: 12022: 1
2002high 1 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K014083Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. · 2002 · cites it directly5descendants
  • K101907Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 2010 · 2 generations on4descendants
  • K120586Cell Saver EliteHaemonetics Corp. · 2012 · 3 generations on3descendants
  • K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation · 2016 · 4 generations on2descendants
  • K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation · 2017 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932890Cell Saver 5 SystemHaemonetics Corp.1994—
+1K014083Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp.20023
+2K101907Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp.20106
+3K120586Cell Saver EliteHaemonetics Corp.2012—
+4K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation2016—
+5K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201010
201210
201610
201710
202210
FIG. 1 — Lineage of K932890, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K240426 Aventus Clot Management Systemscore 11.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K014083Haemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp.20025

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 21, 2019Class IIZ-0886-2020Device DesignPotential 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, 2019Class IIZ-0887-2020Device DesignPotential 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, 2019Class IIZ-0888-2020Device DesignPotential 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, 2019Class IIZ-0891-2020Device DesignPotential 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, 2019Class IIZ-0885-2020Device DesignPotential 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, 2019Class IIZ-0889-2020Device DesignPotential 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, 2019Class IIZ-0890-2020Device DesignPotential 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…
Dec 17, 2002Not classifiedZ-0498-03OtherDisposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002Not classifiedZ-0499-03OtherDisposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002Not classifiedZ-0501-03OtherDisposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002Not classifiedZ-0500-03OtherDisposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002Not classifiedZ-0502-03OtherDisposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002Not classifiedZ-0503-03OtherDisposable Set for Autologous Blood recovery may leak saline at the Y-connector

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K014083 (Haemonetics Corp., 2002) has gone furthest, with 5 descendants of its own.

How does its category compare?

All CAC devices

CAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAC

3in 2024

2008: 12010: 42011: 22012: 32013: 12014: 32016: 22017: 12018: 22019: 12020: 12021: 42022: 12023: 22024: 3
2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAC

91in 2024

2010: 123 days median2012: 90 days median2014: 269 days median2021: 155 days median2024: 91 days median
2007high 269 (2014) · low 90 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAC

7in 2023

2007: 12008: 52009: 252010: 32011: 32013: 92017: 22018: 22019: 232023: 7, 2 Class I
2007high 25 (2009) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CAC

128in 2025

2007: 352008: 122009: 682010: 1152011: 9392012: 2492013: 1532014: 902015: 872016: 732017: 882018: 872019: 642020: 1082021: 732022: 652023: 392024: 1292025: 128
2007high 939 (2011) · low 12 (2008)2025

MAUDE reports naming product code CAC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—135
20081—512
20090—2568
201041233115
20112—3939
20123900249
20131—9153
20143269090
20150—087
20162—073
20171—288
20182—287
20191—2364
20201—0108
20214155073
20221—065
20232—7 (2)39
20243910129
20250—0128
20260—0—

More from Haemonetics Corp.

28 FDA decisions under this applicant name. See the company

  • K122262Orthopat Advance Perioperative Autotransfusion SystemHaemonetics Corp. · 20121 recall
  • K120586Cell Saver EliteHaemonetics Corp. · 2012
  • K101907Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 20106 recalls
  • K062801Smartsuction Solo DeviceHaemonetics Corp. · 2006
  • K061103Haemonetics 40U RBC Filter BagHaemonetics Corp. · 2006

Recent decisions in CAC

The CAC category page

  • K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
  • K240426Aventus Clot Management SystemInquis Medical · 2024
  • K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024
  • K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc. · 2023
  • K221483FlowSaver Blood Return SystemInari Medical, Inc. · 2023

https://510kreport.com/device/K932890 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932890: Cell Saver 5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932890

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026