510(k) · Cleared
ClearedBlood Hand Pump Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Alaris Products · BRZ Set, Blood Transfusion
Cleared on Apr 1, 2005 as substantially equivalent to K882302 (Y, 1988) and 1 other predicate after a 73-day review. Its family tree reaches back 1 generation to 1988. 7 later devices descend from it.
- Decided
- Apr 1, 2005
- Review
- 73 days
- Class
- Class II
- Product code
- BRZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881321 (1988). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK881321 Blood/Solution Set W/Pressure PumpBaxter Healthcare Corp · 1988 · Recalled
- This deviceK050115 Blood Hand Pump Administration SetCardinal Health, Alaris Products · 2005
- Descendant · cites it directly · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK153731 LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK213588 Q2 IV Administration SetsQuest Medical, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK202618 IV Administration SetsB.Braun Medical, Inc. · 2021 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · cites it directly6descendants
- K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · 2 generations on3descendants
- K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016 · 2 generations on1descendant
- K213588Q2 IV Administration SetsQuest Medical, Inc. · 2022 · 3 generations on0descendants
- K202618IV Administration SetsB.Braun Medical, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881321 | Blood/Solution Set W/Pressure Pump | Baxter Healthcare Corp | 1988 | 8 |
| 0 (this device) | K050115 | Blood Hand Pump Administration Set | Cardinal Health, Alaris Products | 2005 | — |
| +1 | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +2 | K170595 | IV Administration Sets | B.Braun Medical, Inc. | 2017 | 19 |
| +2 | K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) | 410 Medical Innovation, LLC | 2016 | — |
| +3 | K213588 | Q2 IV Administration Sets | Quest Medical, Inc. | 2022 | — |
| +3 | K202618 | IV Administration Sets | B.Braun Medical, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K882302 | Ivac (R) Unvented Vol. Infusion Set Model 52080Summary page 2…predicate devices: redcate Devce e : Manuifactrer. 59(k): No. Date Cleared ALARIS Blood Cardinal Health, Alaris K882302 7/12/1988 Administration Set Products Baxter Fenwal Y-Type Baxter Corporation K8813… | 1988 |
| * | K881321 | Blood/Solution Set W/Pressure PumpSummary page 2…Cardinal Health, Alaris K882302 7/12/1988 Administration Set Products Baxter Fenwal Y-Type Baxter Corporation K881321 6/16/1998 Blood/Solution Set INTENDED USE The Blood Hand Pump Set will be used for patients that require blood. The… | 1988 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140838 | IV Administration Set with Hand Pump | 2014 | 6 |
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?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K140838 (B.Braun Medical, Inc., 2014) 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?
A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050115: Blood Hand Pump Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050115
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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