510(k) · Cleared
ClearedBecton Dickinson Syringes
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 25, 1998 after a 128-day review. The FDA summary names its predicate without a number. 2 of the 142 devices in its family, counting itself, have a Class I recall. 141 later devices descend from it.
- Decided
- Jun 25, 1998
- Review
- 128 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
141 later devices descend from it, 9 citing it directly. 2 of the 142 devices in this family, counting this one, have a Class I recall.
- This deviceK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- Descendant · cites it directly · 111 of its ownK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 88 of its ownK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
- Descendant · 3 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- Descendant · 4 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- Descendant · 3 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
Showing 5 of 141 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 141 · See all- K024052Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003 · cites it directly111descendants
- K070936Welmed Hypodermic SyringeWelmed, Inc. · 2007 · 2 generations on88descendants
- K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 3 generations on78descendants
- K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 4 generations on36descendants
- K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| +1 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| +2 | K070936 | Welmed Hypodermic Syringe | Welmed, Inc. | 2007 | — |
| +3 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| +4 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| +3 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 1 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 1 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 17 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 0 |
| 2024 | 9 | 0 |
| 2025 | 11 | 0 |
| 2026 | 4 | 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 and Insulin Syringes Named without a submission number |
What descends from it? (141)
See all 1419 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024052 | Merit Medical 1-ML Syringe | 2003 | 111 |
| K023752 | BD Integra Syringe | 2003 | 16 |
| K050134 | Icc Insulin Safepro Safety Syringe | 2005 | 6 |
| K991758 | Monoject Insulin Syringe | 1999 | 3 |
| K203453 | BD Hypodermic Syringe | 2021 | 0 |
| K121270 | Bioject Needle-Free Injection Management System | 2012 | 0 |
| K110112 | Cell-Tissue Converter (CTC) Syringe with Needle | 2011 | 0 |
| K081547 | Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC | 2008 | 0 |
| K062753 | Forsure Disposable Syringe with Needle, Model 1CC, 3C, 5CC, 10CC, 20CC, 50CC | 2007 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K024052 (Merit Medical Systems, Inc., 2003) has gone furthest, with 111 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?
The general use syringes are intended for the aspiration and injection of fluids. Insulin syringes are intended for the injection of insulin.
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/K980580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980580: Becton Dickinson Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980580
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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