510(k) · Cleared
ClearedUltra-Fine™ SAFETY Insulin Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
embecta Medical II, LLC · FMF Syringe, Piston
Cleared on Jul 13, 2026 as substantially equivalent to K190054 (Becton, Dickinson and Company, 2019) after a 171-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jul 13, 2026
- Review
- 171 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941657 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK941657 BD Micro Fine, Ultra Fine, and Allergy SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 3 generations backK024112 BD Insulin SyringeBecton, Dickinson & CO · 2003 · Recalled
- 2 generations backK170386 BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe…Becton Dickinson & Company · 2017
- 1 generation backK190054 BD Insulin SyringeBecton, Dickinson and Company · 2019 · Recalled
- This deviceK260208 Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941657 | BD Micro Fine, Ultra Fine, and Allergy Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| −3 | K024112 | BD Insulin Syringe | Becton, Dickinson & CO | 2003 | 3 |
| −2 | K170386 | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin… | Becton Dickinson & Company | 2017 | — |
| −1 | K190054 | BD Insulin Syringe | Becton, Dickinson and Company | 2019 | 8 |
| 0 (this device) | K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K190054 | BD Insulin SyringeSummary page 5…inge, Piston) MEG (Syringe, Antistick) Predicate Device Legally marketed predicate device to which substantial equivalence is being claimed: K190054 – BD Insulin Syringe Device Description The Ultra-Fine SAFETY Insulin Syringe is a single-use, plastic, sterile, non-pyrogenic d… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 8.6 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K190054.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Ultra-Fine SAFETY Insulin Syringes are intended to be used for subcutaneous administration of insulin for the treatment of diabetes mellitus at a concentration of 100U/mL (U-100), while reducing the occurrence of accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
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/K260208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260208: Ultra-Fine™ SAFETY 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/K260208
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026