510(k) · Cleared
ClearedTianjin Medis Disposable Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Medis International Trade Co., Ltd. · FPA Set, Administration, Intravascular
Cleared on Mar 31, 2006 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Mar 31, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK060082 Tianjin Medis Disposable Infusion SetTianjin Medis International Trade Co., Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK090012 Disposable Infusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK234129 Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK254123 Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
- Descendant · cites it directly · 0 of its ownK090459 Disposable Tpe Infusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009
Most influential descendants
Showing 4 of 4 · See all- K090012Disposable Infusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009 · cites it directly2descendants
- K234129Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2024 · 2 generations on1descendant
- K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026 · 3 generations on0descendants
- K090459Disposable Tpe Infusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060082 | Tianjin Medis Disposable Infusion Set | Tianjin Medis International Trade Co., Ltd. | 2006 | — |
| +1 | K090012 | Disposable Infusion Set | Shan Dong Wei Gao Group Medical Polymer Products | 2009 | 2 |
| +2 | K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2024 | — |
| +3 | K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2026 | — |
| +1 | K090459 | Disposable Tpe Infusion Set | Shan Dong Wei Gao Group Medical Polymer Products | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 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?
- Of its descendants, K090012 (Shan Dong Wei Gao Group Medical Polymer Products, 2009) has gone furthest, with 2 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?
Tianjin Medis Disposable Infusion set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060082: Tianjin Medis Disposable Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060082
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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