510(k) · Cleared
ClearedModification to BD Eclipse Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 29, 2004 as substantially equivalent to K010188 (Bd Medical Systems, 2001) after a 19-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Dec 29, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010188 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010188 BD Eclipse Hypodermic NeedleBd Medical Systems · 2001
- This deviceK043397 Modification to BD Eclipse Hypodermic NeedleBecton, Dickinson & CO · 2004
- Descendant · cites it directly · 1 of its ownK100209 BD Eclipse Needle with Smartslip TechnologyBecton, Dickinson & CO · 2010
- Descendant · 2 generations on · 0 of its ownK214004 CCBIO ASCPO NeedleCc Biotechnology Corporation · 2022
- Descendant · cites it directly · 0 of its ownK121283 BD Emerald Saf-T Single Use, HypodermicBecton, Dickinson and Company · 2012
- Descendant · cites it directly · 0 of its ownK082908 Novaguard, Model 3611001West Pharmaceutical Services, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K100209BD Eclipse Needle with Smartslip TechnologyBecton, Dickinson & CO · 2010 · cites it directly1descendant
- K214004CCBIO ASCPO NeedleCc Biotechnology Corporation · 2022 · 2 generations on0descendants
- K121283BD Emerald Saf-T Single Use, HypodermicBecton, Dickinson and Company · 2012 · cites it directly0descendants
- K082908Novaguard, Model 3611001West Pharmaceutical Services, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010188 | BD Eclipse Hypodermic Needle | Bd Medical Systems | 2001 | — |
| 0 (this device) | K043397 | Modification to BD Eclipse Hypodermic Needle | Becton, Dickinson & CO | 2004 | — |
| +1 | K100209 | BD Eclipse Needle with Smartslip Technology | Becton, Dickinson & CO | 2010 | — |
| +2 | K214004 | CCBIO ASCPO Needle | Cc Biotechnology Corporation | 2022 | — |
| +1 | K121283 | BD Emerald Saf-T Single Use, Hypodermic | Becton, Dickinson and Company | 2012 | — |
| +1 | K082908 | Novaguard, Model 3611001 | West Pharmaceutical Services, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K010188 | BD Eclipse Hypodermic NeedleSummary page 1…edle Manufactured by: Becton Dickinson and Company 4. Device Description: The BD EclipseTm Hypodermic Needle (BD EclipseFm Hypodermic Needle 5 10(k): K0101 88) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting cover that is connect… | 2001 |
What descends from it? (4)
3 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?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The BD EclipseTM Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD EclipseTM Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes.
The BD EclipseTM Hypodermic Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043397: Modification to BD Eclipse Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043397
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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