510(k) · Cleared
ClearedBD Emerald Single Use, Hypodermic Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson · FMF Syringe, Piston
Cleared on Nov 28, 2011 as substantially equivalent to K980987 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Nov 28, 2011
- Review
- 26 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K980987 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK980987 Becton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 1 generation backK110771 BD Single Use, Hypodermic SyringeBecton, Dickinson and Company · 2011 · Recalled
- This deviceK113241 BD Emerald Single Use, Hypodermic SyringeBecton Dickinson · 2011
- Descendant · cites it directly · 0 of its ownK210914 Sterile Syringe for Single UseJiangsu Suyun Medical Material Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK121283 BD Emerald Saf-T Single Use, HypodermicBecton, Dickinson and Company · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980987 | Becton Dickinson Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 15 |
| −1 | K110771 | BD Single Use, Hypodermic Syringe | Becton, Dickinson and Company | 2011 | 10 |
| 0 (this device) | K113241 | BD Emerald Single Use, Hypodermic Syringe | Becton Dickinson | 2011 | — |
| +1 | K210914 | Sterile Syringe for Single Use | Jiangsu Suyun Medical Material Co., Ltd. | 2021 | — |
| +1 | K121283 | BD Emerald Saf-T Single Use, Hypodermic | Becton, Dickinson and Company | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 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 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? (2)
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 |
|---|---|---|---|
| * | K980987 | Becton Dickinson SyringeSummary page 1…Trade Name(s): Becton Dickinson Single Use Hypodermic Syringe. Manuifacturer: Becton, Dickinson and Company 5 10(k) Number(s): K980987 and K110771 4. Device Description: The B5l Emeraldml Single Use, Hypodermic Syringe is a tree-piece sterile, single… | 1998 |
| * | K110771 | BD Single Use, Hypodermic SyringeSummary page 1…e(s): Becton Dickinson Single Use Hypodermic Syringe. Manuifacturer: Becton, Dickinson and Company 5 10(k) Number(s): K980987 and K110771 4. Device Description: The B5l Emeraldml Single Use, Hypodermic Syringe is a tree-piece sterile, single *use, hy… | 2011 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K210914 (Jiangsu Suyun Medical Material Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K980987.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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) | — |
What is it indicated for?
The BD Emerald Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113241: BD Emerald Single Use, Hypodermic Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113241
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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