510(k) · Cleared
ClearedSterile Single-use Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Hongda Medical Equipment Group, Ltd. · FPA Set, Administration, Intravascular
Cleared on Apr 20, 2017 after a 161-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Apr 20, 2017
- Review
- 161 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 4 citing it directly.
- This deviceK163160 Sterile Single-use Infusion SetJiangxi Hongda Medical Equipment Group, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK232475 Disposable infusion set with needleShandong Zhushi Pharmaceutical Group Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK221069 Infusion Sets for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK221075 Infusion Sets for Single UseSichuan Prius Biotechnology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK202437 Infusion Sets for Single UseJiangsu Suyun Medical Materials Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K232475Disposable infusion set with needleShandong Zhushi Pharmaceutical Group Co., Ltd. · 2024 · cites it directly0descendants
- K221069Infusion Sets for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd. · 2022 · cites it directly0descendants
- K221075Infusion Sets for Single UseSichuan Prius Biotechnology Co., Ltd. · 2022 · cites it directly0descendants
- K202437Infusion Sets for Single UseJiangsu Suyun Medical Materials Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K163160 | Sterile Single-use Infusion Set | Jiangxi Hongda Medical Equipment Group, Ltd. | 2017 | — |
| +1 | K232475 | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2024 | — |
| +1 | K221069 | Infusion Sets for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022 | — |
| +1 | K221075 | Infusion Sets for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022 | — |
| +1 | K202437 | Infusion Sets for Single Use | Jiangsu Suyun Medical Materials Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2024 | 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; 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 | K112204 | KDL Disposable Infusion Set Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…cap of luer lock connector. The devices are provided sterile and single use. 5. Identification of Predicate Device Premark Notification 510(k) Number: K112204 Trade Name: KDL Disposable Infusion Set Classification Name: Set, Administration, Intravascular Manufacturer: Shan… |
What descends from it? (4)
4 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, K232475 (Shandong Zhushi Pharmaceutical Group Co., Ltd., 2024) has gone furthest, with 0 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. 2017, 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 device is intended to administer fluids from a container to a patient’s vascular system through a needle or catheter
inserted into the vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163160 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163160: Sterile Single-use Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163160
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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