510(k) · Cleared
ClearedHaemonetics 40U RBC Filter Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · CAK Microfilter, Blood Transfusion
Cleared on May 17, 2006 as substantially equivalent to K942844 (Level 1 Technologies, Inc., 1996) after a 27-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- May 17, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- CAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942844 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK942844 Level 1 Blood Stream Recovery SystemLevel 1 Technologies, Inc. · 1996
- This deviceK061103 Haemonetics 40U RBC Filter BagHaemonetics Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942844 | Level 1 Blood Stream Recovery System | Level 1 Technologies, Inc. | 1996 | — |
| 0 (this device) | K061103 | Haemonetics 40U RBC Filter Bag | Haemonetics Corp. | 2006 | — |
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 CAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K942844 | Level 1 Blood Stream Recovery SystemSummary page 1…component) Predicate Device The predicate device is the Filter Bag, BF-40, of the Harvest® BloodStream® Recovery System. The Harvest Filter Bag device was cleared in K942844 on 4/26/96. Haemonetics acquired this product line from Harvest in August 2004. Description The Haemonetics 40't RBC Filter Bag… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All CAK devicesCAK Microfilter, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAK
FDA has decided no CAK device since 2007.
Median 510(k) review, days · CAK
Too few CAK 510(k)s in any year since 2007 to give a median.
Recalls per year · CAK
No recall names CAK since 2007.
Adverse event reports per year · CAK
60in 2025
MAUDE reports naming product code CAK, 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 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 37 |
| 2015 | 0 | — | 0 | 58 |
| 2016 | 0 | — | 0 | 97 |
| 2017 | 0 | — | 0 | 131 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 0 | — | 0 | 334 |
| 2020 | 0 | — | 0 | 180 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 0 | 110 |
| 2023 | 0 | — | 0 | 69 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 60 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Haemonetics 40g RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061103: Haemonetics 40U RBC Filter Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061103
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