510(k) · Cleared
ClearedIV Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Jun 26, 2018 as substantially equivalent to K151151 (U&U Medical Technology Co, Ltd., 2015) after a 243-day review. Its family tree reaches back 4 generations to 1983. 1 later device descends from it.
- Decided
- Jun 26, 2018
- Review
- 243 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K832284 (1983). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK832284 Solution Admin. Set 2C9096 W/10 PVCTravenol Laboratories, S.A. · 1983 · Recalled
- 3 generations backK981792 Solution Administration SetBaxter Healthcare Corp · 1998 · Recalled
- 2 generations backK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- 1 generation backK151151 U & U Intravascular Administration SetU&U Medical Technology Co, Ltd. · 2015
- This deviceK173361 IV Administration SetB.Braun Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK213778 IV Administration SetB.Braun Medical, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213778IV Administration SetB.Braun Medical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983 | 2 |
| −3 | K981792 | Solution Administration Set | Baxter Healthcare Corp | 1998 | 5 |
| −2 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| −1 | K151151 | U & U Intravascular Administration Set | U&U Medical Technology Co, Ltd. | 2015 | — |
| 0 (this device) | K173361 | IV Administration Set | B.Braun Medical, Inc. | 2018 | — |
| +1 | K213778 | IV Administration Set | B.Braun Medical, Inc. | 2022 | — |
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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K151151 | U & U Intravascular Administration SetSummary page 4…80.5440 General Hospital PREDICATE DEVICE: U & U Intravascular Administration Set, U & U Medical Technology Co., Ltd., K151151, Class II, FPA, 21 CFR 880.5440 General Hospital Description IV Administration Sets are gravi… | 2015 |
| † | K031923 | Ultrasite Valve | 2003 |
| † | K931377 | Safeline System IV Administration Sets & Component | 1994 |
| † | K083723 | A6 Luer Access Device | 2009 |
| † | K140311 | Caresite Luer Access Device | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213778 | IV Administration Set | 2022 | 0 |
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 35 years and passes through 5 companies; a new generation was cleared every 14.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K213778 (B.Braun Medical, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K151151.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
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/K173361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173361: IV 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/K173361
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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