510(k) · Cleared
ClearedTaky-Spike Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinico · LHI Set, I.V. Fluid Transfer
Cleared on Dec 22, 1997 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 22, 1997
- Review
- 42 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK974198 Taky-Spike PlusClinico · 1997
- Descendant · cites it directly · 4 of its ownK062482 Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006
- Descendant · 2 generations on · 2 of its ownK160503 Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK221406 Vented Vial Transfer PinJiangsu Caina Medical Co.,Ltd · 2022
- Descendant · 3 generations on · 0 of its ownK213513 Vented Vial Adapter 20mmWest Pharma. Services IL, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK122265 Vialok Single Vial Access Device VentedYukon Medical, LLC · 2012
Most influential descendants
Showing 5 of 5 · See all- K062482Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006 · cites it directly4descendants
- K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. · 2016 · 2 generations on2descendants
- K221406Vented Vial Transfer PinJiangsu Caina Medical Co.,Ltd · 2022 · 3 generations on0descendants
- K213513Vented Vial Adapter 20mmWest Pharma. Services IL, Ltd. · 2022 · 3 generations on0descendants
- K122265Vialok Single Vial Access Device VentedYukon Medical, LLC · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974198 | Taky-Spike Plus | Clinico | 1997 | — |
| +1 | K062482 | Vented Vial Adapter Transfer Device | Medimop Medical Projects, Ltd. | 2006 | — |
| +2 | K160503 | Vented Vial Adapter Transfer Device - 13mm | Medimop Medical Projects, Ltd. | 2016 | — |
| +3 | K221406 | Vented Vial Transfer Pin | Jiangsu Caina Medical Co.,Ltd | 2022 | — |
| +3 | K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2022 | — |
| +2 | K122265 | Vialok Single Vial Access Device Vented | Yukon Medical, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062482 | Vented Vial Adapter Transfer Device | 2006 | 4 |
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, K062482 (Medimop Medical Projects, Ltd., 2006) has gone furthest, with 4 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 | — |
What is it indicated for?
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Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974198 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974198: Taky-Spike Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974198
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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