510(k) · Cleared
ClearedSummit Medical LTD Celltrans Postoperative Autotransfusion System, Models ABT4510, ABT4512 & ABT4514
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 Oct 9, 2002 as substantially equivalent to K951592 (Duxbury Scientific, Inc., 1996) after a 72-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it.
- Decided
- Oct 9, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951592 (1996). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951592 Betatrans I and IIDuxbury Scientific, Inc. · 1996
- This deviceK022489 Summit Medical LTD Celltrans Postoperative Autotransfusion System…Summit Medical, Ltd. · 2002
- Descendant · cites it directly · 7 of its ownK024097 Summit Medical LTD Celltrans Postoperative Autotransfusion Set…Summit Medical, Ltd. · 2003
- Descendant · 2 generations on · 6 of its ownK210176 FlowSaver Blood FilterInari Medical · 2021
- Descendant · 3 generations on · 3 of its ownK240426 Aventus Clot Management SystemInquis Medical · 2024
- Descendant · 4 generations on · 2 of its ownK253925 Aventus Thrombectomy SystemInquis Medical · 2026
- Descendant · 3 generations on · 1 of its ownK221483 FlowSaver Blood Return SystemInari Medical, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K024097Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models AB400-10…Summit Medical, Ltd. · 2003 · cites it directly7descendants
- K210176FlowSaver Blood FilterInari Medical · 2021 · 2 generations on6descendants
- K240426Aventus Clot Management SystemInquis Medical · 2024 · 3 generations on3descendants
- K253925Aventus Thrombectomy SystemInquis Medical · 2026 · 4 generations on2descendants
- K221483FlowSaver Blood Return SystemInari Medical, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951592 | Betatrans I and II | Duxbury Scientific, Inc. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K210176 | FlowSaver Blood Filter | Inari Medical | 2021 | — |
| +3 | K240426 | Aventus Clot Management System | Inquis Medical | 2024 | — |
| +4 | K253925 | Aventus Thrombectomy System | Inquis Medical | 2026 | — |
| +3 | K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K951592 | Betatrans I and IISummary page 1…rative Autotransfusion Transfusion System I Classification Name Autotransfusion Apparatus Predicate Product Betatrans Orthopaedic Autotransfusion System (K951592), Duxbury Scientific Inc. Product Description The CellTransTMdevice consists of a sterile, double wrapped package, containing… | 1996 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024097 | Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models AB400-10… | 2003 | 7 |
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.
- Of its descendants, K024097 (Summit Medical, Ltd., 2003) has gone furthest, with 7 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 System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022489: Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models ABT4510, ABT4512 & ABT4514.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022489
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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