510(k) · Cleared
Recalled · 2004Modified Blood Recipient Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · BRZ Set, Blood Transfusion
Cleared on Nov 17, 1999 after a 58-day review. The FDA summary names its predicate without a number. 2 of the 10 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 10 times.
- Decided
- Nov 17, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- BRZ
- Recalls
- 10
- Predicates
- 0
9 later devices descend from it, 2 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- This deviceK993120 Modified Blood Recipient SetBaxter Healthcare Corp · 1999
- Descendant · cites it directly · 6 of its ownK021293 Arteria Blood FilterArteria Medical Science, Inc. · 2002
- Descendant · 2 generations on · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK210335 Blood Administration SetBaxter Healthcare Corporation · 2021
- Descendant · 4 generations on · 1 of its ownK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K021293Arteria Blood FilterArteria Medical Science, Inc. · 2002 · cites it directly6descendants
- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · 2 generations on5descendants
- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · 3 generations on2descendants
- K210335Blood Administration SetBaxter Healthcare Corporation · 2021 · cites it directly1descendant
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993120 | Modified Blood Recipient Set | Baxter Healthcare Corp | 1999 | — |
| +1 | K021293 | Arteria Blood Filter | Arteria Medical Science, Inc. | 2002 | — |
| +2 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +3 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +1 | K210335 | Blood Administration Set | Baxter Healthcare Corporation | 2021 | — |
| +4 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 BRZ device
- #1 K220558 Blood Administration Setsscore 4.7 · 2 generations · 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 |
|---|---|---|---|
| * | — | Blood /Solution Sets Named without a submission number |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2004 | Not classified | Z-0193-05 | Other | Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device. |
| Jul 16, 2003 | Not classified | Z-1160-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1161-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1176-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1172-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1177-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1175-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1178-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1162-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1171-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
The 5 latest of 10 recalls; the web page lists all.
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 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021293 (Arteria Medical Science, Inc., 2002) has gone furthest, with 6 descendants of its own.
How does its category compare?
All BRZ devicesBRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BRZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · BRZ
Too few BRZ 510(k)s in any year since 2007 to give a median.
Recalls per year · BRZ
No recall names BRZ since 2007.
Adverse event reports per year · BRZ
70in 2025
MAUDE reports naming product code BRZ, 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 | 12 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 71 |
| 2011 | 0 | — | 0 | 123 |
| 2012 | 0 | — | 0 | 141 |
| 2013 | 1 | — | 0 | 175 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 0 | — | 0 | 171 |
| 2016 | 0 | — | 0 | 78 |
| 2017 | 0 | — | 0 | 82 |
| 2018 | 0 | — | 0 | 66 |
| 2019 | 0 | — | 0 | 85 |
| 2020 | 0 | — | 0 | 90 |
| 2021 | 1 | — | 0 | 60 |
| 2022 | 1 | — | 0 | 55 |
| 2023 | 0 | — | 0 | 67 |
| 2024 | 0 | — | 0 | 89 |
| 2025 | 0 | — | 0 | 70 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The modified Baxter blood sets have the same intended use as currently marketed Baxter blood sets. The intended use of these sets is the administration of blood, blood components or solutions from a container into the patient’s vascular system through a vascular access device.
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/K993120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993120: Modified Blood Recipient Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993120
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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