510(k) · Cleared
ClearedInfusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan W.E.O Science & Technology Development Co., Ltd. · FPA Set, Administration, Intravascular
Cleared on Feb 26, 2019 as substantially equivalent to K161898 (Beijing Fert Technology Co., Ltd., 2017) and 2 other predicates after a 229-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Feb 26, 2019
- Review
- 229 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K974661 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK974661 0.2 U Bacterial FilterSims Deltec, Inc. · 1998
- This deviceK181870 Infusion Sets with Precision Filter for Single Use, Precision…Wuhan W.E.O Science & Technology Development Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974661 | 0.2 U Bacterial Filter | Sims Deltec, Inc. | 1998 | — |
| 0 (this device) | K181870 | Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter… | Wuhan W.E.O Science & Technology Development Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K161898 | Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision…Summary page 4…Sets for Single Use) FPB (Infusion Line Filter) Predicate Devices: Infusion Sets with Precision Filter for Single Use Predicate Device 510(K) Number: K161898 Product Name: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set… | 2017 |
| * | K974661 | 0.2 U Bacterial FilterSummary page 5…1/8 Precision Infusion Filter for Single Use Predicate Device 510(K) Number: K974661 Product Name: 0.2μ bacterial filter Extended Infusion Sets for Single Use Predicate Device 510(K) Number: K061115 Product Name:… | 1998 |
| * | K061115 | Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215; Easydrop…Summary page 5…Filter for Single Use Predicate Device 510(K) Number: K974661 Product Name: 0.2μ bacterial filter Extended Infusion Sets for Single Use Predicate Device 510(K) Number: K061115 Product Name: SPE E DF LOW 0 .2U M F I L T E R, M OD EL 1 1 2 1 4; SP EED FLO W 1.2UM F IL T E R , M OD EL 1 1215 ; EA SY DROP CO… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only.
The Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications.
The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181870 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181870: Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181870
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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