510(k) · Cleared
Recalled · Class II · 2016BD Eclipse Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FMI Needle, Hypodermic, Single Lumen
Cleared on May 27, 2016 as substantially equivalent to K010188 (Bd Medical Systems, 2001) after a 31-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- May 27, 2016
- Review
- 31 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010188 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010188 BD Eclipse Hypodermic NeedleBd Medical Systems · 2001
- This deviceK161170 BD Eclipse Hypodermic NeedleBecton, Dickinson and Company · 2016
- Descendant · cites it directly · 1 of its ownK162081 BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic…Becton, Dickinson and Company · 2016
- Descendant · 2 generations on · 0 of its ownK222852 Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation · 2023
- Descendant · cites it directly · 0 of its ownK213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…Becton, Dickinson and Company · 2016 · cites it directly1descendant
- K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation · 2023 · 2 generations on0descendants
- K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022 · 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) | K161170 | BD Eclipse Hypodermic Needle | Becton, Dickinson and Company | 2016 | — |
| +1 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with… | Becton, Dickinson and Company | 2016 | — |
| +2 | K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation | 2023 | — |
| +1 | K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Medline Industries, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 4…ypodermic, Single Lumen Predicate Devices: Trade Name: BD EclipseTM Hypodermic Needle 510(k) Reference: K010188 Common Name: Hypodermic Single Lumen Needle Classifica… | 2001 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Dec 20, 2016 | Class II | Z-1440-2017 | Device Design | BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries. |
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. 2016, 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 Eclipse™ 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 Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint 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/K161170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161170: 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/K161170
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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