510(k) · Cleared
ClearedAccess Concentration System, Model Acc-100, Access Disposable Set, Model Ads-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · CAC Apparatus, Autotransfusion
Cleared on Aug 15, 2002 as substantially equivalent to K012406 (Interpore Cross Intl., 2002) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Aug 15, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963759 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK963759 Dideco Compact-a and Compact-M Autotransfusion SystemsSorin Biomedical, Inc. · 1998
- 1 generation backK012406 Access Sequestration SystemInterpore Cross Intl. · 2002
- This deviceK022348 Access Concentration System, Model Acc-100, Access Disposable Set…Interpore Cross Intl. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963759 | Dideco Compact-a and Compact-M Autotransfusion Systems | Sorin Biomedical, Inc. | 1998 | — |
| −1 | K012406 | Access Sequestration System | Interpore Cross Intl. | 2002 | — |
| 0 (this device) | K022348 | Access Concentration System, Model Acc-100, Access Disposable Set, Model… | Interpore Cross Intl. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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.
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 4 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
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 Interpore Cross International AccessTM System is intended to separate and collect an autologous plasma fraction rich in platelets and white cells from the patient’s whole blood perioperative to a surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022348: Access Concentration System, Model Acc-100, Access Disposable Set, Model Ads-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022348
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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