510(k) · Cleared
ClearedBD Eclipse Needle with Smartslip Technology
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 Feb 19, 2010 as substantially equivalent to K010188 (Bd Medical Systems, 2001) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Feb 19, 2010
- Review
- 25 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010188 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010188 BD Eclipse Hypodermic NeedleBd Medical Systems · 2001
- 1 generation backK043397 Modification to BD Eclipse Hypodermic NeedleBecton, Dickinson & CO · 2004
- This deviceK100209 BD Eclipse Needle with Smartslip TechnologyBecton, Dickinson & CO · 2010
- Descendant · cites it directly · 0 of its ownK214004 CCBIO ASCPO NeedleCc Biotechnology Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K214004CCBIO ASCPO NeedleCc Biotechnology Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010188 | BD Eclipse Hypodermic Needle | Bd Medical Systems | 2001 | — |
| −1 | K043397 | Modification to BD Eclipse Hypodermic Needle | Becton, Dickinson & CO | 2004 | — |
| 0 (this device) | K100209 | BD Eclipse Needle with Smartslip Technology | Becton, Dickinson & CO | 2010 | — |
| +1 | K214004 | CCBIO ASCPO Needle | Cc Biotechnology Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 Needle | 2001 |
| * | K043397 | Modification to BD Eclipse Hypodermic NeedleSummary page 2…R 4. Device Description: The BD EclipSe TMl Hypodermic Needle (831) Eclipse T m Hypodermic Needle 510(k): K0l0l 88 and K043397 with the metal clip) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214004 | CCBIO ASCPO Needle | 2022 | 0 |
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 9 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K214004 (Cc Biotechnology Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K010188.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Eclipser11i Needle with SrnartSlipTm Technology 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 J3D Eclipse""" Needle with SiiartSlipTM Technology is compatible for use with standard luer-slip and luer-lock syringes.
TEhe BD Eclipsen"I Needle with SniartSl~ipTnI Technology contains a mechanism that covers the needle point afiter use. In the activated position the needle cover" guards against accidental needle sticks durinp- normal handling and disposal of the used -needle/syringe combination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100209: BD Eclipse Needle with Smartslip Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100209
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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