510(k) · Cleared
ClearedHealth Line International Corporations,S IV Administrative Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Line International Corporation · FPA Set, Administration, Intravascular
Cleared on May 31, 2006 after a 107-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 2 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- May 31, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
13 later devices descend from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK060352 Health Line International Corporations,S IV Administrative SetsHealth Line International Corporation · 2006
- Descendant · cites it directly · 12 of its ownK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- Descendant · 2 generations on · 5 of its ownK151151 U & U Intravascular Administration SetU&U Medical Technology Co, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK232316 DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024
- Descendant · 3 generations on · 1 of its ownK230343 ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK173361 IV Administration SetB.Braun Medical, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K120685Zyno Medical Administration SetZyno Medical, LLC · 2012 · cites it directly12descendants
- K151151U & U Intravascular Administration SetU&U Medical Technology Co, Ltd. · 2015 · 2 generations on5descendants
- K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024 · 2 generations on1descendant
- K230343ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd. · 2023 · 3 generations on1descendant
- K173361IV Administration SetB.Braun Medical, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060352 | Health Line International Corporations,S IV Administrative Sets | Health Line International Corporation | 2006 | — |
| +1 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| +2 | K151151 | U & U Intravascular Administration Set | U&U Medical Technology Co, Ltd. | 2015 | — |
| +2 | K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024 | — |
| +3 | K230343 | ProSeal™ Closed System Administration Set | Epic Medical Pte., Ltd. | 2023 | — |
| +3 | K173361 | IV Administration Set | B.Braun Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0925126 | Baxter Number could not be read | |
| Kept off the family tree | K089098 | Baxter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120685 | Zyno Medical Administration Set | 2012 | 12 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA…Zyno Medical, LLC · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K120685 (Zyno Medical, LLC, 2012) has gone furthest, with 12 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 indicated use of health Line International Corporation's IV Administration Sets and Extensions Sets is for administration of fluids from a container to the patents vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060352: Health Line International Corporations,S IV Administrative Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060352
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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