510(k) · Cleared
ClearedCharter Medical, LTD MP 450 (40 Micron Filter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Charter Medical, Ltd. · CAK Microfilter, Blood Transfusion
Cleared on Aug 30, 1999 as substantially equivalent to K811985 (Pall Biomedical Products Co., 1981) after a 210-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Aug 30, 1999
- Review
- 210 days
- Class
- Class II
- Product code
- CAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811985 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK811985 Ultipor SQ40S Blood Transfusion FilterPall Biomedical Products Co. · 1981
- This deviceK990310 Charter Medical, LTD MP 450 (40 Micron Filter)Charter Medical, Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811985 | Ultipor SQ40S Blood Transfusion Filter | Pall Biomedical Products Co. | 1981 | — |
| 0 (this device) | K990310 | Charter Medical, LTD MP 450 (40 Micron Filter) | Charter Medical, Ltd. | 1999 | — |
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 |
|---|---|---|---|
| * | K811985 | Ultipor SQ40S Blood Transfusion FilterSummary page 1…Predicate Device SQ™40S 40-Micron Screen Filter manufactured by PALL Biomedical Products Company was determined by FDA to be substantially equivalent in July 1981 (Ref: K811985) Pace & 14JANGG harkar kdadiscal LA SECTION 1.0 - 510(k) SUMMARY December 7, 1998 Charter Medical, Ltd. 40 Micro… | 1981 |
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?
- Its one ancestor has no recall.
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?
Single use device for the removal of microaggregate and particulate debris from whole blood and red blood cells (RBCs) during infusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990310: Charter Medical, LTD MP 450 (40 Micron Filter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990310
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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