510(k) · Cleared
ClearedBecton Dickinson Syringse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · FMF Syringe, Piston
Cleared on Nov 21, 1995 after an 83-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.
- Decided
- Nov 21, 1995
- Review
- 83 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK954064 Becton Dickinson SyringseBd Becton Dickinson Vacutainer Systems Preanalytic · 1995
- Descendant · cites it directly · 11 of its ownK071108 Texium SyringeCardinal Health, Alaris Products · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK083152 Equashield SystemPlastmed, Ltd. · 2009
- Descendant · 3 generations on · 8 of its ownK091389 Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009
- Descendant · 3 generations on · 7 of its ownK101940 Equashield System Protective PlusEquashield Medical, Ltd. · 2010
- Descendant · 4 generations on · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K071108Texium SyringeCardinal Health, Alaris Products · 2007 · cites it directly11descendants
- K083152Equashield SystemPlastmed, Ltd. · 2009 · 2 generations on9descendants
- K091389Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009 · 3 generations on8descendants
- K101940Equashield System Protective PlusEquashield Medical, Ltd. · 2010 · 3 generations on7descendants
- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954064 | Becton Dickinson Syringse | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | — |
| +1 | K071108 | Texium Syringe | Cardinal Health, Alaris Products | 2007 | 1 |
| +2 | K083152 | Equashield System | Plastmed, Ltd. | 2009 | — |
| +3 | K091389 | Equalshield Luer Lock Connector Pair | Plastmed, Ltd. | 2009 | — |
| +3 | K101940 | Equashield System Protective Plus | Equashield Medical, Ltd. | 2010 | — |
| +4 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 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 |
|---|---|---|---|
| * | — | Becton Dickinson Single Use Hypodermic Syringes Named without a submission number |
What descends from it? (17)
See all 172 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, K071108 (Cardinal Health, Alaris Products, 2007) has gone furthest, with 11 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
https://510kreport.com/device/K954064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954064: Becton Dickinson Syringse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954064
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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