510(k) · Cleared
ClearedChemo Mini Spike Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun of America, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Mar 23, 1999 as substantially equivalent to K925401 (B. Braun of America, Inc., 1993) after a 147-day review. Its family tree reaches back 1 generation to 1993. 13 later devices descend from it.
- Decided
- Mar 23, 1999
- Review
- 147 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925401 (1993). 13 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK925401 IV Fluid Transfer PinB. Braun of America, Inc. · 1993 · Recalled
- This deviceK983794 Chemo Mini Spike PlusB. Braun of America, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK052790 Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005
- 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 · cites it directly · 1 of its ownK201469 Mini Spike Plus 6/8RB.Braun Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK151963 SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K052790Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005 · cites it directly5descendants
- 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
- K201469Mini Spike Plus 6/8RB.Braun Medical, Inc. · 2020 · cites it directly1descendant
- K151963SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925401 | IV Fluid Transfer Pin | B. Braun of America, Inc. | 1993 | 1 |
| 0 (this device) | K983794 | Chemo Mini Spike Plus | B. Braun of America, Inc. | 1999 | — |
| +1 | K052790 | Smartsite Vented Vial Access Device, Model TBD | Cardinal Health, Alaris Products | 2005 | — |
| +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 | — |
| +1 | K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | 2020 | — |
| +2 | K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K925401 | IV Fluid Transfer PinSummary page 1…Trade Name: Chemo Mini Spike Plus Classification name: General Hospital Class Il, 8OLHI 21 CFR 880.5440 SUBSTANTIAL EQUIVALENCE! TO: 510()number | Name | Applicant K925401 L.V. Fluid Transfer Pin B. Braun Medical Inc. Device Description: In accordance with section 510(k) for the Federal Food, Drug,… | 1993 |
What descends from it? (13)
See all 133 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?
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?
An IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983794: Chemo Mini Spike Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983794
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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