510(k) · Cleared
ClearedSingle-Fil (TM) Syringe
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 Oct 17, 1988 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 17, 1988
- Review
- 28 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK883955 Single-Fil (TM) SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- Descendant · cites it directly · 8 of its ownK042934 1BD Soloshot IX SyringeBecton, Dickinson & CO · 2004
- Descendant · 2 generations on · 5 of its ownK201234 BD SoloShot Mini Syringe/ BD Auto Disable SyringeBecton, Dickinson and Company · 2020
- Descendant · 3 generations on · 2 of its ownK210464 Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK212920 Sterile Safety Syringe with Needle for Single Use, Sterile Safety…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK091377 BD Flu+ SyringeBecton, Dickinson & CO · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K0429341BD Soloshot IX SyringeBecton, Dickinson & CO · 2004 · cites it directly8descendants
- K201234BD SoloShot Mini Syringe/ BD Auto Disable SyringeBecton, Dickinson and Company · 2020 · 2 generations on5descendants
- K210464Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd. · 2021 · 3 generations on2descendants
- K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022 · 3 generations on1descendant
- K091377BD Flu+ SyringeBecton, Dickinson & CO · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883955 | Single-Fil (TM) Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| +1 | K042934 | 1BD Soloshot IX Syringe | Becton, Dickinson & CO | 2004 | — |
| +2 | K201234 | BD SoloShot Mini Syringe/ BD Auto Disable Syringe | Becton, Dickinson and Company | 2020 | — |
| +3 | K210464 | Auto Disable Syringe | Anhui Tiankang Medical Technology Co., Ltd. | 2021 | — |
| +3 | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic… | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022 | — |
| +2 | K091377 | BD Flu+ Syringe | Becton, Dickinson & CO | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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 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 16.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042934 | 1BD Soloshot IX Syringe | 2004 | 8 |
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, K042934 (Becton, Dickinson & CO, 2004) has gone furthest, with 8 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/K883955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883955: Single-Fil (TM) Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883955
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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