510(k) · Cleared
ClearedVial Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on Mar 10, 2023 as substantially equivalent to K171796 (Medimop Medical Project, Ltd., 2017) after a 183-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 10, 2023
- Review
- 183 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963583 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK963583 Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable…Medimop Medical Projects, Ltd. · 1996
- 1 generation backK171796 Vial Adapter 15mmMedimop Medical Project, Ltd. · 2017
- This deviceK222718 Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK233287 Vent Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK233284 Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963583 | Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder… | Medimop Medical Projects, Ltd. | 1996 | — |
| −1 | K171796 | Vial Adapter 15mm | Medimop Medical Project, Ltd. | 2017 | — |
| 0 (this device) | K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2023 | — |
| +1 | K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024 | — |
| +1 | K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171796 | Vial Adapter 15mmSummary page 4…name: Set, I.V. Fluid Transfer Classification: Class II, 21 CFR 880.5440 Product Code: LHI Premarket Notification: K171796 Manufacturer: Medimop Medical Projects Ltd IV Device description The Vial Adapter consists of luer connector,… | 2017 |
What descends from it? (2)
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 21.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233287 (Hangzhou Qiantang Longyue Biotechnology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K171796.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222718: Vial Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222718
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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