510(k) · Cleared
ClearedFlowSaver Blood Return System (80-101)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical, Inc. · CAC Apparatus, Autotransfusion
Cleared on Jul 14, 2023 as substantially equivalent to K221483 (Inari Medical, Inc., 2023) after a 28-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jul 14, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951592 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK951592 Betatrans I and IIDuxbury Scientific, Inc. · 1996
- 4 generations backK022489 Summit Medical LTD Celltrans Postoperative Autotransfusion System…Summit Medical, Ltd. · 2002
- 3 generations backK024097 Summit Medical LTD Celltrans Postoperative Autotransfusion Set…Summit Medical, Ltd. · 2003
- 2 generations backK210176 FlowSaver Blood FilterInari Medical · 2021
- 1 generation backK221483 FlowSaver Blood Return SystemInari Medical, Inc. · 2023
- This deviceK231782 FlowSaver Blood Return System (80-101)Inari Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951592 | Betatrans I and II | Duxbury Scientific, Inc. | 1996 | — |
| −4 | K022489 | Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models… | Summit Medical, Ltd. | 2002 | — |
| −3 | K024097 | Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models… | Summit Medical, Ltd. | 2003 | — |
| −2 | K210176 | FlowSaver Blood Filter | Inari Medical | 2021 | — |
| −1 | K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | 2023 | — |
| 0 (this device) | K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K221483 | FlowSaver Blood Return SystemSummary page 4…Classification number 21 CFR 868.5830 Product code CAC Regulatory class II Predicate device Inari Medical, FlowSaver Blood Return System (K221483) Description The FlowSaver Blood Return System accessory allows for autologous injection of… | 2023 |
| † | K210176 | FlowSaver Blood Filter | 2021 |
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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Inari Medical catheters and sheaths for autologous blood transfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231782: FlowSaver Blood Return System (80-101).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231782
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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