510(k) · Cleared
ClearedMixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle
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 Oct 7, 1996 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 19 later devices descend from it.
- Decided
- Oct 7, 1996
- Review
- 31 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 6 citing it directly.
- This deviceK963583 Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable…Medimop Medical Projects, Ltd. · 1996
- Descendant · cites it directly · 6 of its ownK171796 Vial Adapter 15mmMedimop Medical Project, Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK062482 Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006
- Descendant · cites it directly · 3 of its ownK041691 Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK222718 Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK160503 Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K171796Vial Adapter 15mmMedimop Medical Project, Ltd. · 2017 · cites it directly6descendants
- K062482Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006 · cites it directly4descendants
- K041691Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004 · cites it directly3descendants
- K222718Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2023 · 2 generations on2descendants
- K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | K062482 | Vented Vial Adapter Transfer Device | Medimop Medical Projects, Ltd. | 2006 | — |
| +1 | K041691 | Clip 'N'ject Reconstitution System (Clip 'N'ject | West Pharmaceutical Services, Inc. | 2004 | — |
| +2 | K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2023 | — |
| +2 | K160503 | Vented Vial Adapter Transfer Device - 13mm | Medimop Medical Projects, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (19)
See all 196 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, K171796 (Medimop Medical Project, Ltd., 2017) has gone furthest, with 6 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K963583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963583: Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963583
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026