510(k) · Cleared

Cleared

BD Eclipse Hypodermic Needle

K010188510(k) TraditionalCleared Mar 1, 200138-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bd Medical Systems · FMI Needle, Hypodermic, Single Lumen

Cleared on Mar 1, 2001 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided: Mar 1, 2001
Review: 38 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 0

14 later devices descend from it, 7 citing it directly.

This deviceK010188 BD Eclipse Hypodermic NeedleBd Medical Systems · 2001
Descendant · cites it directly · 4 of its ownK043397 Modification to BD Eclipse Hypodermic NeedleBecton, Dickinson & CO · 2004
Descendant · cites it directly · 3 of its ownK161170 BD Eclipse Hypodermic NeedleBecton, Dickinson and Company · 2016 · Recalled
Descendant · cites it directly · 2 of its ownK123684 Sol-Care Safety NeedleSol-Millennium Medical · 2013 · Recalled
Descendant · 2 generations on · 1 of its ownK162081 BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic…Becton, Dickinson and Company · 2016
Descendant · cites it directly · 1 of its ownK100209 BD Eclipse Needle with Smartslip TechnologyBecton, Dickinson & CO · 2010

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2004high 2 (2016) · low 0 (2005)2026

Most influential descendants

Showing 5 of 14 · See all

K043397Modification to BD Eclipse Hypodermic NeedleBecton, Dickinson & CO · 2004 · cites it directly4descendants
K161170BD Eclipse Hypodermic NeedleBecton, Dickinson and Company · 2016 · cites it directly3descendants
K123684Sol-Care Safety NeedleSol-Millennium Medical · 2013 · cites it directly2descendants
K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…Becton, Dickinson and Company · 2016 · 2 generations on1descendant
K100209BD Eclipse Needle with Smartslip TechnologyBecton, Dickinson & CO · 2010 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010188	BD Eclipse Hypodermic Needle	Bd Medical Systems	2001	—
+1	K043397	Modification to BD Eclipse Hypodermic Needle	Becton, Dickinson & CO	2004	—
+1	K161170	BD Eclipse Hypodermic Needle	Becton, Dickinson and Company	2016	1
+1	K123684	Sol-Care Safety Needle	Sol-Millennium Medical	2013	2
+2	K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with…	Becton, Dickinson and Company	2016	—
+1	K100209	BD Eclipse Needle with Smartslip Technology	Becton, Dickinson & CO	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2009	1	0
2010	1	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2016	2	0
2022	2	0
2023	2	0

FIG. 1 — Lineage of K010188, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K043397	Modification to BD Eclipse Hypodermic Needle	Becton, Dickinson & CO	2004	4
K161170	BD Eclipse Hypodermic Needle	Becton, Dickinson and Company	2016	3
K123684	Sol-Care Safety Needle	Sol-Millennium Medical	2013	2
K100209	BD Eclipse Needle with Smartslip Technology	Becton, Dickinson & CO	2010	1
K130097	Medmate Transfer Adapter AM5500 & AM5500-NS	American Medical Manufacturing, Inc./ Advanced Med	2014	0
K121283	BD Emerald Saf-T Single Use, Hypodermic	Becton, Dickinson and Company	2012	0
K073206	Needle-Trap/Needle Safety Label	Schreiner Medipharm	2008	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?

Of its descendants, K043397 (Becton, Dickinson & CO, 2004) has gone furthest, with 4 descendants of its own.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)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)	—

https://510kreport.com/device/K010188 · printed Nov 5, 2026

Cite this page

510(k) Report. “K010188: BD Eclipse Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010188

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026