510(k) · Cleared
ClearedWuzhou Syringe, with/Without Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzhou Wuzhou Group Co., Ltd. · FMF Syringe, Piston
Cleared on Feb 10, 2006 as substantially equivalent to K042500 (Duopross Meditech Corporation, 2005) after a 14-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it.
- Decided
- Feb 10, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000572 (2000). 9 ancestors in all, the oldest K980987 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 4 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 3 generations backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 2 generations backK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- 1 generation backK042500 Duopross SyringesDuopross Meditech Corporation · 2005
- This deviceK060211 Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK222925 Hypodermic Syringes & NeedleLifelong Meditech Private Limited · 2023
- Descendant · cites it directly · 0 of its ownK222124 Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210103 Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited · 2021
Most influential descendants
Showing 3 of 3 · See all- K222925Hypodermic Syringes & NeedleLifelong Meditech Private Limited · 2023 · cites it directly0descendants
- K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · cites it directly0descendants
- K210103Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −4 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −3 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −2 | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | M.K. Meditech Co., Ltd. | 2003 | — |
| −1 | K042500 | Duopross Syringes | Duopross Meditech Corporation | 2005 | — |
| 0 (this device) | K060211 | Wuzhou Syringe, with/Without Needle | Wenzhou Wuzhou Group Co., Ltd. | 2006 | — |
| +1 | K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | 2023 | — |
| +1 | K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
| +1 | K210103 | Safeway, Lifelong Premium, Lifelong Matrix | Lifelong Meditech Private Limited | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042500 | Duopross SyringesSummary page 1…nge 21 C.F.R. 880.5680, Product Code FME. Class It Hypodermic Single Lumen Needle 21 C.F.R. 880.5570, Product Code FMI, Class T Predicate Device: The DuoProSS Syringe (K042500) manufactured by DuoProSS Meditech Corporation. Intended Use: The Wuzhou Syringe, with/without needle is intended to be used fo… | 2005 |
What descends from it? (3)
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 6 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K222925 (Lifelong Meditech Private Limited, 2023) has gone furthest, with 0 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.
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 Wuzhou Syringe, with/without needle for single use only, is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060211: Wuzhou Syringe, with/Without Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060211
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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