510(k) · Cleared
ClearedU & U Intravascular Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&U Medical Technology Co, Ltd. · FPA Set, Administration, Intravascular
Cleared on Sep 24, 2015 as substantially equivalent to K120685 (Zyno Medical, LLC, 2012) after a 147-day review. Its family tree reaches back 3 generations to 1983. 5 later devices descend from it.
- Decided
- Sep 24, 2015
- Review
- 147 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K832284 (1983). 5 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK832284 Solution Admin. Set 2C9096 W/10 PVCTravenol Laboratories, S.A. · 1983 · Recalled
- 2 generations backK981792 Solution Administration SetBaxter Healthcare Corp · 1998 · Recalled
- 1 generation backK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- This deviceK151151 U & U Intravascular Administration SetU&U Medical Technology Co, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK230343 ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK173361 IV Administration SetB.Braun Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK251814 EZ™ IV Administration SetEpic Medical Pte., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK213778 IV Administration SetB.Braun Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK191640 TK Intravascular Administration SetAnhui Tiankang Medical Technology Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K230343ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd. · 2023 · cites it directly1descendant
- K173361IV Administration SetB.Braun Medical, Inc. · 2018 · cites it directly1descendant
- K251814EZ™ IV Administration SetEpic Medical Pte., Ltd. · 2025 · 2 generations on0descendants
- K213778IV Administration SetB.Braun Medical, Inc. · 2022 · 2 generations on0descendants
- K191640TK Intravascular Administration SetAnhui Tiankang Medical Technology Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983 | 2 |
| −2 | K981792 | Solution Administration Set | Baxter Healthcare Corp | 1998 | 5 |
| −1 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| 0 (this device) | K151151 | U & U Intravascular Administration Set | U&U Medical Technology Co, Ltd. | 2015 | — |
| +1 | K230343 | ProSeal™ Closed System Administration Set | Epic Medical Pte., Ltd. | 2023 | — |
| +1 | K173361 | IV Administration Set | B.Braun Medical, Inc. | 2018 | — |
| +2 | K251814 | EZ™ IV Administration Set | Epic Medical Pte., Ltd. | 2025 | — |
| +2 | K213778 | IV Administration Set | B.Braun Medical, Inc. | 2022 | — |
| +1 | K191640 | TK Intravascular Administration Set | Anhui Tiankang Medical Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K120685 | Zyno Medical Administration SetSummary page 4…bmission Type: 510(k) Regulation Number: 880.5440 3. Predicate Devices Information: Trade Name: Zyno Medical Administration Set 510(K) Number: K120685 4. Devices Description: The U&U Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxid… | 2012 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 4 companies; a new generation was cleared every 14.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K230343 (Epic Medical Pte., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K120685.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The U&U Intravascular Administration Set is a device used to administer fluids from a container 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/K151151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151151: U & U Intravascular 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/K151151
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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