510(k) · Cleared
ClearedBlood Transfusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shan Dong Wei Gao Group Medical Polymer Products · BRZ Set, Blood Transfusion
Cleared on Apr 10, 2009 as substantially equivalent to K041496 (Pentaferte S.P.A, 2005) after a 148-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Apr 10, 2009
- Review
- 148 days
- Class
- Class II
- Product code
- BRZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924721 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK924721 Baxter Solution Administration SetsBaxter Healthcare Corp · 1993 · Recalled
- 2 generations backK023039 Blood/Solution Administration Set, Model 33.015Tuta Healthcare Pty Limited · 2002
- 1 generation backK041496 Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 2005
- This deviceK083349 Blood Transfusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924721 | Baxter Solution Administration Sets | Baxter Healthcare Corp | 1993 | 5 |
| −2 | K023039 | Blood/Solution Administration Set, Model 33.015 | Tuta Healthcare Pty Limited | 2002 | — |
| −1 | K041496 | Pentatrasfu Blood Transfusion Sets | Pentaferte S.P.A | 2005 | — |
| 0 (this device) | K083349 | Blood Transfusion Set | Shan Dong Wei Gao Group Medical Polymer Products | 2009 | — |
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 BRZ? 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 |
|---|---|---|---|
| * | K041496 | Pentatrasfu Blood Transfusion SetsSummary page 2…035 Product Code: BRZ Regulation Number: 880.5440 Device Class: II 5. Predicate Device Identification: PENTATRASFU Blood Transfusion Sets K-number: K041496 6. Intended Use: Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to… | 2005 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All BRZ devicesBRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083349: Blood Transfusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083349
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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