510(k) · Cleared
ClearedSummit Medical LTD Transfusion Filter, Model LF400 & Summit Medical LTD Transfusion Filter with Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Medical, Ltd. · CAK Microfilter, Blood Transfusion
Cleared on Oct 25, 2002 as substantially equivalent to K960993 (Pall Biomedical Products Co., 1996) after an 88-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- CAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960993 (1996). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960993 Pall SQ40S Blood Filter (SQ40S/SQ40ST)Pall Biomedical Products Co. · 1996 · Recalled
- This deviceK022477 Summit Medical LTD Transfusion Filter, Model LF400 & Summit Medical…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 | K960993 | Pall SQ40S Blood Filter (SQ40S/SQ40ST) | Pall Biomedical Products Co. | 1996 | 1 |
| 0 (this device) | K022477 | Summit Medical LTD Transfusion Filter, Model LF400 & Summit Medical LTD… | 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 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 |
|---|---|---|---|
| * | K960993 | Pall SQ40S Blood Filter (SQ40S/SQ40ST)Summary page 1…Device Name Transfusion Filter Classification Name Microfilter, Blood Transfusion Predicate Product SQ40 Blood Transfusion Filter, Pall Biomedical Products Co. (K960993) Product Description The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly… | 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 a recall.
- Of its descendants, K024097 (Summit Medical, Ltd., 2003) has gone furthest, with 7 descendants of its own.
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 Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022477 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022477: Summit Medical LTD Transfusion Filter, Model LF400 & Summit Medical LTD Transfusion Filter with Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022477
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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