510(k) · Cleared
ClearedMHC Standard and NRFit Tip Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mazza Healthcare, LLC · FMF Syringe, Piston
Cleared on Nov 8, 2017 as substantially equivalent to K170218 (Vesco Medical, LLC, 2017) and 1 other predicate after a 205-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Nov 8, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931367 (1993). 26 ancestors in all, the oldest K822083 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 6 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 5 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 4 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 3 generations backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- 2 generations backK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
- 1 generation backK170218 Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 2017
- This deviceK171131 MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC · 2017
- Descendant · cites it directly · 0 of its ownK212764 Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −6 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −5 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −4 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −3 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| −2 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
| −1 | K170218 | Vesco Medical NRFit Tip Syringes | Vesco Medical, LLC | 2017 | — |
| 0 (this device) | K171131 | MHC Standard and NRFit Tip Syringes | Mazza Healthcare, LLC | 2017 | — |
| +1 | K212764 | Medwell Technology Ltd Syringes, various sizes | Medwell Technology, Ltd. | 2022 | — |
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 | 3 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K170218 | Vesco Medical NRFit Tip SyringesSummary page 4…Regulatory Class: Class II Product Code: FMF Primary Predicate: Vesco Medical NRFitTM Tip Syringes 510(k): K170218 cleared February 24, 2017 Predicate Device: DMC Medical Single-Use Polycarbonate Syringe 510(k):… | 2017 |
| * | K103736 | DMC Medical Single-Use Polycarbonate SyringeSummary page 4…510(k): K170218 cleared February 24, 2017 Predicate Device: DMC Medical Single-Use Polycarbonate Syringe 510(k): K103736 cleared June 10, 2011 Device Description: The MHC Standard and NRFitTM Tip Syringes are provided sterile or in bulk non-sterile… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212764 | Medwell Technology Ltd Syringes, various sizes | 2022 | 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?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K212764 (Medwell Technology, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K170218.
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 MHC Standard and NRFitTM 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/K171131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171131: MHC Standard and NRFit Tip Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171131
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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