510(k) · Cleared
ClearedMini Spike Plus 6/8R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Dec 9, 2020 as substantially equivalent to K983794 (B. Braun of America, Inc., 1999) after a 189-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Dec 9, 2020
- Review
- 189 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925401 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK925401 IV Fluid Transfer PinB. Braun of America, Inc. · 1993 · Recalled
- 1 generation backK983794 Chemo Mini Spike PlusB. Braun of America, Inc. · 1999
- This deviceK201469 Mini Spike Plus 6/8RB.Braun Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK260301 Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925401 | IV Fluid Transfer Pin | B. Braun of America, Inc. | 1993 | 1 |
| −1 | K983794 | Chemo Mini Spike Plus | B. Braun of America, Inc. | 1999 | — |
| 0 (this device) | K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | 2020 | — |
| +1 | K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K983794 | Chemo Mini Spike PlusSummary page 4…e: Vial Adapter / IV Fluid Transfer Set Classification Name: Intravascular Administration Set; 21 CFR 880.5440 510(k) Number: K983794 The predicate device 510(k) clearance for K983794 covers three models of the device Mini- Spike Plus. Substantial equivale… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260301 | Vial Adapter | 2026 | 0 |
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 2 companies; a new generation was cleared every 21.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K260301 (Hangzhou Qiantang Longyue Biotechnology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K983794.
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. 2020, 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?
An 1V additive dispensing pin for aspiration from single-dose containers with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R).
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/K201469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201469: Mini Spike Plus 6/8R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201469
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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