510(k) · Cleared
ClearedSummit Medical LTD Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Medical, Ltd. · CAC Apparatus, Autotransfusion
Cleared on Feb 14, 2003 as substantially equivalent to K022489 (Summit Medical, Ltd., 2002) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it.
- Decided
- Feb 14, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951592 (1996). 4 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK951592 Betatrans I and IIDuxbury Scientific, Inc. · 1996
- 1 generation backK022489 Summit Medical LTD Celltrans Postoperative Autotransfusion System…Summit Medical, Ltd. · 2002
- This deviceK024097 Summit Medical LTD Celltrans Postoperative Autotransfusion Set…Summit Medical, Ltd. · 2003
- Descendant · cites it directly · 6 of its ownK210176 FlowSaver Blood FilterInari Medical · 2021
- Descendant · 2 generations on · 3 of its ownK240426 Aventus Clot Management SystemInquis Medical · 2024
- Descendant · 3 generations on · 2 of its ownK253925 Aventus Thrombectomy SystemInquis Medical · 2026
- Descendant · 2 generations on · 1 of its ownK221483 FlowSaver Blood Return SystemInari Medical, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK261105 Powered Aventus Thrombectomy System™Inquis Medical · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210176FlowSaver Blood FilterInari Medical · 2021 · cites it directly6descendants
- K240426Aventus Clot Management SystemInquis Medical · 2024 · 2 generations on3descendants
- K253925Aventus Thrombectomy SystemInquis Medical · 2026 · 3 generations on2descendants
- K221483FlowSaver Blood Return SystemInari Medical, Inc. · 2023 · 2 generations on1descendant
- K261105Powered Aventus Thrombectomy System™Inquis Medical · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951592 | Betatrans I and II | Duxbury Scientific, Inc. | 1996 | — |
| −1 | K022489 | Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models… | Summit Medical, Ltd. | 2002 | — |
| 0 (this device) | K024097 | Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models… | Summit Medical, Ltd. | 2003 | — |
| +1 | K210176 | FlowSaver Blood Filter | Inari Medical | 2021 | — |
| +2 | K240426 | Aventus Clot Management System | Inquis Medical | 2024 | — |
| +3 | K253925 | Aventus Thrombectomy System | Inquis Medical | 2026 | — |
| +2 | K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | 2023 | — |
| +4 | K261105 | Powered 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K022489 | Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models ABT4510…Summary page 2…erative Autotransfusion Set Classification Name Autotransfusion Apparatus Predicate Product(s) Summit Medical CellTransTMPostoperative Autotransfusion System (K022489) Summit Medical Transfusion Filter (K022477) Product Description The CellTransTMPostoperative Autotransfusion Set consis… | 2002 |
| * | K022477 | Summit Medical LTD Transfusion Filter, Model LF400 & Summit Medical LTD Transfusion…Summary page 2…utotransfusion Apparatus Predicate Product(s) Summit Medical CellTransTMPostoperative Autotransfusion System (K022489) Summit Medical Transfusion Filter (K022477) Product Description The CellTransTMPostoperative Autotransfusion Set consists of two individually sterilized packages, contain… | 2002 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210176 | FlowSaver Blood Filter | 2021 | 6 |
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 7 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K210176 (Inari Medical, 2021) has gone furthest, with 6 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 Summit Medical CellTransTMPostoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024097 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024097: Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024097
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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