510(k) · Cleared
ClearedFlowSaver Blood Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical · CAC Apparatus, Autotransfusion
Cleared on Jul 22, 2021 as substantially equivalent to K024097 (Summit Medical, Ltd., 2003) after a 181-day review. Its family tree reaches back 3 generations to 1996. 6 later devices descend from it.
- Decided
- Jul 22, 2021
- Review
- 181 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951592 (1996). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK951592 Betatrans I and IIDuxbury Scientific, Inc. · 1996
- 2 generations backK022489 Summit Medical LTD Celltrans Postoperative Autotransfusion System…Summit Medical, Ltd. · 2002
- 1 generation backK024097 Summit Medical LTD Celltrans Postoperative Autotransfusion Set…Summit Medical, Ltd. · 2003
- This deviceK210176 FlowSaver Blood FilterInari Medical · 2021
- Descendant · cites it directly · 3 of its ownK240426 Aventus Clot Management SystemInquis Medical · 2024
- Descendant · 2 generations on · 2 of its ownK253925 Aventus Thrombectomy SystemInquis Medical · 2026
- Descendant · cites it directly · 1 of its ownK221483 FlowSaver Blood Return SystemInari Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK261105 Powered Aventus Thrombectomy System™Inquis Medical · 2026
- Descendant · 3 generations on · 0 of its ownK262030 Aventus Thrombectomy SystemInquis Medical · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K240426Aventus Clot Management SystemInquis Medical · 2024 · cites it directly3descendants
- K253925Aventus Thrombectomy SystemInquis Medical · 2026 · 2 generations on2descendants
- K221483FlowSaver Blood Return SystemInari Medical, Inc. · 2023 · cites it directly1descendant
- K261105Powered Aventus Thrombectomy System™Inquis Medical · 2026 · 3 generations on0descendants
- K262030Aventus Thrombectomy SystemInquis Medical · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951592 | Betatrans I and II | Duxbury Scientific, Inc. | 1996 | — |
| −2 | K022489 | Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models… | Summit Medical, Ltd. | 2002 | — |
| −1 | K024097 | Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models… | Summit Medical, Ltd. | 2003 | — |
| 0 (this device) | K210176 | FlowSaver Blood Filter | Inari Medical | 2021 | — |
| +1 | K240426 | Aventus Clot Management System | Inquis Medical | 2024 | — |
| +2 | K253925 | Aventus Thrombectomy System | Inquis Medical | 2026 | — |
| +1 | K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | 2023 | — |
| +3 | K261105 | Powered Aventus Thrombectomy System™ | Inquis Medical | 2026 | — |
| +3 | K262030 | Aventus Thrombectomy System | Inquis Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K024097 | Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models AB400-10…Summary page 4…ratus Classification number 21 CFR 868.5830 Product code CAC Regulatory class II Predicate device CellTrans Postoperative Autotransfusion Set, K024097 This predicate has not been subject to a design-related recall. Reference device(s) FlowTriever Retri… | 2003 |
| † | K191710 | FlowTriever Retrieval/Aspiration System | 2019 |
| † | K000685 | Charter Medical Neonatal Syringe Set | 2000 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K240426 (Inquis Medical, 2024) 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. 2021, 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 FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210176: FlowSaver Blood Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210176
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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