510(k) · Cleared
Cleared1ML Luer-Lok Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · FMF Syringe, Piston
Cleared on May 26, 1994 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 26, 1994
- Review
- 55 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK941562 1ML Luer-Lok SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 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 · cites it directly · 0 of its ownK243322 Altaviz Intravitreal SyringeAltaviz, LLC · 2025
- 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 ownK062865 Small Volume SyringeAlcon Laboratories · 2007
- Descendant · cites it directly · 0 of its ownK022495 Gettig Disposable SyringesGettig Pharmaceutical Instrument Co. · 2002
Most influential descendants
Showing 5 of 5 · 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
- K243322Altaviz Intravitreal SyringeAltaviz, LLC · 2025 · cites it directly0descendants
- K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation · 2023 · 2 generations on0descendants
- K062865Small Volume SyringeAlcon Laboratories · 2007 · cites it directly0descendants
- K022495Gettig Disposable SyringesGettig Pharmaceutical Instrument Co. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941562 | 1ML Luer-Lok Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| +1 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with… | Becton, Dickinson and Company | 2016 | — |
| +1 | K243322 | Altaviz Intravitreal Syringe | Altaviz, LLC | 2025 | — |
| +2 | K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation | 2023 | — |
| +1 | K062865 | Small Volume Syringe | Alcon Laboratories | 2007 | — |
| +1 | K022495 | Gettig Disposable Syringes | Gettig Pharmaceutical Instrument Co. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
4 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?
- Of its descendants, K162081 (Becton, Dickinson and Company, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K941562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941562: 1ML Luer-Lok Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941562
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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