510(k) · Cleared
ClearedSyringes, With or without Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangyin Caina Technology Co., Ltd. · FMF Syringe, Piston
Cleared on Oct 28, 2011 after a 9-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 7 later devices descend from it.
- Decided
- Oct 28, 2011
- Review
- 9 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
7 later devices descend from it, 3 citing it directly.
- This deviceK113091 Syringes, With or without NeedlesJiangyin Caina Technology Co., Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK170218 Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK171131 MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK212764 Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK182765 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass…Top Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK181374 NRFit SyringeJiangsu Caina Medical Co.,Ltd · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170218Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 2017 · cites it directly4descendants
- K171131MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC · 2017 · 2 generations on1descendant
- K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022 · 3 generations on0descendants
- K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial…Top Corporation · 2019 · 2 generations on0descendants
- K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113091 | Syringes, With or without Needles | Jiangyin Caina Technology Co., Ltd. | 2011 | — |
| +1 | K170218 | Vesco Medical NRFit Tip Syringes | Vesco Medical, LLC | 2017 | — |
| +2 | K171131 | MHC Standard and NRFit Tip Syringes | Mazza Healthcare, LLC | 2017 | — |
| +3 | K212764 | Medwell Technology Ltd Syringes, various sizes | Medwell Technology, Ltd. | 2022 | — |
| +2 | K182765 | 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc… | Top Corporation | 2019 | — |
| +2 | K181374 | NRFit Syringe | Jiangsu Caina Medical Co.,Ltd | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K072737 | FDA’s K072737 is CSCS-001A Calcium Scoring Package Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
What descends from it? (7)
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?
- Of its descendants, K170218 (Vesco Medical, LLC, 2017) has gone furthest, with 4 descendants 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. 2011, this device’s year, is highlighted.
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) | — |
What is it indicated for?
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.
Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113091: Syringes, With or without Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113091
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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