510(k) · Cleared
ClearedVented Vial Adapter Transfer Device - 13mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimop Medical Projects, Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on May 4, 2016 as substantially equivalent to K062482 (Medimop Medical Projects, Ltd., 2006) after a 70-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- May 4, 2016
- Review
- 70 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925401 (1993). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK925401 IV Fluid Transfer PinB. Braun of America, Inc. · 1993 · Recalled
- 2 generations backK983794 Chemo Mini Spike PlusB. Braun of America, Inc. · 1999
- 1 generation backK062482 Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006
- This deviceK160503 Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK221406 Vented Vial Transfer PinJiangsu Caina Medical Co.,Ltd · 2022
- Descendant · cites it directly · 0 of its ownK213513 Vented Vial Adapter 20mmWest Pharma. Services IL, Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −3 | K925401 | IV Fluid Transfer Pin | B. Braun of America, Inc. | 1993 | 1 |
| −2 | K983794 | Chemo Mini Spike Plus | B. Braun of America, Inc. | 1999 | — |
| −1 | K062482 | Vented Vial Adapter Transfer Device | Medimop Medical Projects, Ltd. | 2006 | — |
| 0 (this device) | K160503 | Vented Vial Adapter Transfer Device - 13mm | Medimop Medical Projects, Ltd. | 2016 | — |
| +1 | K221406 | Vented Vial Transfer Pin | Jiangsu Caina Medical Co.,Ltd | 2022 | — |
| +1 | K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K062482 | Vented Vial Adapter Transfer DeviceSummary page 4…Class: II Panel Identification: General Hospital Panel Predicate Devices: Vented Vial Adapter Transfer Device, cleared by 510(K) K062482 K160503 Vented Vial Adapter Transfer Device – 13mm Special 510(k)… | 2006 |
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 23 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K221406 (Jiangsu Caina Medical Co.,Ltd, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062482.
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. 2016, 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 Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160503: Vented Vial Adapter Transfer Device - 13mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160503
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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