510(k) · Cleared
ClearedVesco Medical NRFit Tip Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesco Medical, LLC · FMF Syringe, Piston
Cleared on Feb 24, 2017 as substantially equivalent to K113091 (Jiangyin Caina Technology Co., Ltd., 2011) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it.
- Decided
- Feb 24, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931367 (1993). 23 ancestors in all, the oldest K822083 (1982). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 5 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 4 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 3 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 2 generations backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- 1 generation backK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
- This deviceK170218 Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 2017
- Descendant · cites it directly · 1 of its ownK171131 MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK212764 Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK182765 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass…Top Corporation · 2019
- Descendant · cites it directly · 0 of its ownK181374 NRFit SyringeJiangsu Caina Medical Co.,Ltd · 2018
Most influential descendants
Showing 4 of 4 · See all- K171131MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC · 2017 · cites it directly1descendant
- K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022 · 2 generations on0descendants
- K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial…Top Corporation · 2019 · cites it directly0descendants
- K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −5 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −4 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −3 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −2 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| −1 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
| 0 (this device) | K170218 | Vesco Medical NRFit Tip Syringes | Vesco Medical, LLC | 2017 | — |
| +1 | K171131 | MHC Standard and NRFit Tip Syringes | Mazza Healthcare, LLC | 2017 | — |
| +2 | K212764 | Medwell Technology Ltd Syringes, various sizes | Medwell Technology, Ltd. | 2022 | — |
| +1 | K182765 | 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc… | Top Corporation | 2019 | — |
| +1 | K181374 | NRFit Syringe | Jiangsu Caina Medical Co.,Ltd | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 16.2 · 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? (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 |
|---|---|---|---|
| * | K113091 | Syringes, With or without NeedlesSummary page 4…rketed Predicate Devices • Jiangyin Caina Technology Co., Ltd (Caina) Syringes With or Without Needles (Luer Slip/Lock) were cleared under notification K113091. • Shanghai Kindly Enterprises Sterile Hypodermic Syringe for Single Use, With or Without Needle (Luer Slip/Loc… | 2011 |
| * | K112057 | KDL Syringes and NeedleSummary page 4…13091. • Shanghai Kindly Enterprises Sterile Hypodermic Syringe for Single Use, With or Without Needle (Luer Slip/Lock) were cleared under notification K112057. IV. Device Description The Vesco Medical NRFit Tip Syringes are sterile, single use devices consisting of rigid polypr… | 2011 |
What descends from it? (4)
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?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K171131 (Mazza Healthcare, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K113091.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Vesco Medical NRFit Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170218: Vesco Medical NRFit Tip Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170218
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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