510(k) · Cleared
Recalled · Class II · 2023BD Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FMF Syringe, Piston
Cleared on Oct 21, 2019 as substantially equivalent to K170386 (Becton Dickinson & Company, 2017) after a 283-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Oct 21, 2019
- Review
- 283 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941657 (1994). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 2 generations backK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003 · Recalled
- 1 generation backK170386 BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe…Becton Dickinson & Company · 2017
- This deviceK190054 BD Insulin SyringeBecton, Dickinson and Company · 2019
- Descendant · cites it directly · 0 of its ownK260208 Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
- Descendant · cites it directly · 0 of its ownK212499 BD Insulin Syringe (0.3mL)Becton, Dickinson and Company · 2022
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 |
|---|---|---|---|---|---|
| −3 | K941657 | BD Micro Fine, Ultra Fine, and Allergy Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| −2 | K024112 | BD Insulin Syringe | Becton, Dickinson & CO | 2003 | 3 |
| −1 | K170386 | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin… | Becton Dickinson & Company | 2017 | — |
| 0 (this device) | K190054 | BD Insulin Syringe | Becton, Dickinson and Company | 2019 | — |
| +1 | K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026 | — |
| +1 | K212499 | BD Insulin Syringe (0.3mL) | Becton, Dickinson and Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K170386 | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes…Summary page 4…ine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle (K170386) Device Description: The subject BD Insulin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose… | 2017 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2023 | Class II | Z-1238-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Feb 1, 2023 | Class II | Z-1240-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Feb 1, 2023 | Class II | Z-1244-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Feb 1, 2023 | Class II | Z-1243-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Feb 1, 2023 | Class II | Z-1237-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Feb 1, 2023 | Class II | Z-1242-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Feb 1, 2023 | Class II | Z-1241-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Feb 1, 2023 | Class II | Z-1239-2023 | Under Investigation by firm | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K260208 (embecta Medical II, LLC, 2026) has gone furthest, with 0 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. 2019, 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?
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins
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/K190054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190054: BD Insulin Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190054
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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