510(k) · Cleared
ClearedBurette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Fert Technology Co., Ltd. · FPA Set, Administration, Intravascular
Cleared on Mar 8, 2017 after a 240-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Mar 8, 2017
- Review
- 240 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK161898 Burette-type Infusion Sets for Single Use, Disposable Infusion Sets…Beijing Fert Technology Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK181870 Infusion Sets with Precision Filter for Single Use, Precision…Wuhan W.E.O Science & Technology Development Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K181870Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single…Wuhan W.E.O Science & Technology Development Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K161898 | Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with… | Beijing Fert Technology Co., Ltd. | 2017 | — |
| +1 | K181870 | Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter… | Wuhan W.E.O Science & Technology Development Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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…posable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation. 5. Identification of Predicate Device 510(k) Number: K112204 Product Name: KDL Disposable Infusion Set 6. Identification of Reference Device 510(k) Number: K972839 Product Name… | |
| † | K972839 | Protos 100ML Burette Infusion Set/ Protos 150ML Burette Infusion Set | 1997 |
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 |
|---|---|---|---|
| K181870 | Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single… | 2019 | 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?
- Of its descendants, K181870 (Wuhan W.E.O Science & Technology Development Co., Ltd., 2019) 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 devices are indicated for the delivery of fluids from a container to a patient’s vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161898: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161898
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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