510(k) · Cleared
Recalled · Class II · 2026Becton Dickinson 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 Jun 11, 1998 after an 86-day review. The FDA summary names its predicate without a number. 2 of the 114 devices in its family, counting itself, have a Class I recall. 113 later devices descend from it. It has been recalled 15 times.
- Decided
- Jun 11, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 15
- Predicates
- 0
113 later devices descend from it, 18 citing it directly. 2 of the 114 devices in this family, counting this one, have a Class I recall.
- This deviceK980987 Becton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- Descendant · cites it directly · 35 of its ownK070264 50 ML Terumo Syringe for Administration of UV Sensitive Medicines…Terumo Europe N.V. · 2007
- Descendant · 2 generations on · 34 of its ownK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- Descendant · cites it directly · 33 of its ownK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- Descendant · 3 generations on · 32 of its ownK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- Descendant · 2 generations on · 31 of its ownK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 113 · See all- K07026450 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LBTerumo Europe N.V. · 2007 · cites it directly35descendants
- K083514Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009 · 2 generations on34descendants
- K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011 · cites it directly33descendants
- K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd. · 2017 · 3 generations on32descendants
- K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980987 | Becton Dickinson Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| +1 | K070264 | 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB | Terumo Europe N.V. | 2007 | — |
| +2 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| +1 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| +3 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| +2 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 10 | 1 |
| 2018 | 5 | 0 |
| 2019 | 5 | 1 |
| 2020 | 10 | 0 |
| 2021 | 10 | 0 |
| 2022 | 14 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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.
2 devices in this family have a Class I recall. 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? (113)
See all 11318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070264 | 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB | 2007 | 35 |
| K112434 | BD Oral/Enteral Syringe with BD Univia Connection | 2011 | 33 |
| K110771 | BD Single Use, Hypodermic Syringe | 2011 | 17 |
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit | 2012 | 5 |
| K042500 | Duopross Syringes | 2005 | 4 |
| K151766 | BD Single Use, Hypodermic Syringe | 2015 | 2 |
| K113241 | BD Emerald Single Use, Hypodermic Syringe | 2011 | 2 |
| K182589 | BD Plastipak Syringe | 2019 | 1 |
| K090929 | Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for… | 2009 | 1 |
| K042486 | Procedur 10 Syringe Device | 2005 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2026 | Class II | Z-1496-2026 | Under Investigation by firm | During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. |
| Dec 23, 2020 | Class II | Z-1109-2021 | Process control | The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe. |
| Feb 1, 2019 | Class II | Z-2007-2019 | Under Investigation by firm | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines. |
| Oct 2, 2012 | Class II | Z-0564-2013 | Mixed-up of materials/components | BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot. |
| Apr 9, 2007 | Not classified | Z-0813-2007 | Other | Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity. |
| Feb 15, 2007 | Not classified | Z-0719-2007 | Other | The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size. |
| May 25, 2005 | Not classified | Z-1054-05 | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. |
| May 25, 2005 | Not classified | Z-1058-05 | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. |
| May 25, 2005 | Not classified | Z-1055-05 | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. |
| May 25, 2005 | Not classified | Z-1056-05 | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. |
| May 25, 2005 | Not classified | Z-1057-05 | Other | The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose. |
| Aug 4, 2003 | Not classified | Z-1231-03 | Other | Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile |
| Aug 4, 2003 | Not classified | Z-1232-03 | Other | Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile |
| Aug 4, 2003 | Not classified | Z-1233-03 | Other | Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile |
| Aug 4, 2003 | Not classified | Z-1230-03 | Other | Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile |
The 5 latest of 15 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K070264 (Terumo Europe N.V., 2007) has gone furthest, with 35 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) | — |
What is it indicated for?
These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection.
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/K980987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980987: Becton Dickinson Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980987
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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