510(k) · Cleared
ClearedArteria Blood Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arteria Medical Science, Inc. · FPB Filter, Infusion Line
Cleared on Aug 22, 2002 as substantially equivalent to K993120 (Baxter Healthcare Corp, 1999) after a 121-day review. Its family tree reaches back 1 generation to 1999. 2 of the 8 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Aug 22, 2002
- Review
- 121 days
- Class
- Class II
- Product code
- FPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993120 (1999). 6 later devices descend from it, 1 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK993120 Modified Blood Recipient SetBaxter Healthcare Corp · 1999 · Recalled
- This deviceK021293 Arteria Blood FilterArteria Medical Science, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK230402 ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK123156 Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · cites it directly5descendants
- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · 2 generations on2descendants
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 3 generations on1descendant
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on0descendants
- K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993120 | Modified Blood Recipient Set | Baxter Healthcare Corp | 1999 | 10 |
| 0 (this device) | K021293 | Arteria Blood Filter | Arteria Medical Science, Inc. | 2002 | — |
| +1 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +2 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +3 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
| +4 | K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023 | Class I |
| +2 | K123156 | Gore Flow Reversal System Model GFRS073 | W. L. Gore & Associates, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2023 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 FPB device
- #1 K261403 Lipipor NLF1A Infusion Filter, Lipipor NLF2A &…score 11.9 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K993120 | Modified Blood Recipient SetSummary page 1…ration filter Classification Name: Intravascular Administration Set D. Predicate Devices Baxter healthcare Corporation, Blood Administration Set, K993 120 E. Description of Device The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible med… | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083300 | Gore Flow Reversal System | 2009 | 5 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All FPB devicesFPB Filter, Infusion Line: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPB
Too few FPB 510(k)s in any year since 2007 to give a median.
Recalls per year · FPB
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPB
33in 2025
MAUDE reports naming product code FPB, 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 | 14 |
| 2008 | 0 | — | 0 | 44 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 0 | 32 |
| 2011 | 1 | — | 1 | 20 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 0 | — | 0 | 95 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 160 |
| 2022 | 0 | — | 0 | 36 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ArteriA Blood Filter is intended as an accessory for use in the administration of blood, blood components or solutions into a patient’s vascular system through a venous access device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021293 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021293: Arteria Blood Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021293
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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