510(k) · Cleared
ClearedDuopross Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Duopross Meditech Corporation · FMF Syringe, Piston
Cleared on Feb 22, 2005 as substantially equivalent to K020623 (M.K. Meditech Co., Ltd., 2002) and 4 other predicates after a 161-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- Feb 22, 2005
- Review
- 161 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K000572 (2000). 8 ancestors in all, the oldest K980987 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 3 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 2 generations backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 1 generation backK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- This deviceK042500 Duopross SyringesDuopross Meditech Corporation · 2005
- Descendant · cites it directly · 3 of its ownK060211 Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK222925 Hypodermic Syringes & NeedleLifelong Meditech Private Limited · 2023
- Descendant · 2 generations on · 0 of its ownK222124 Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK210103 Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited · 2021
Most influential descendants
Showing 4 of 4 · See all- K060211Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006 · cites it directly3descendants
- K222925Hypodermic Syringes & NeedleLifelong Meditech Private Limited · 2023 · 2 generations on0descendants
- K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · 2 generations on0descendants
- K210103Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −3 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −2 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −1 | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | M.K. Meditech Co., Ltd. | 2003 | — |
| 0 (this device) | K042500 | Duopross Syringes | Duopross Meditech Corporation | 2005 | — |
| +1 | K060211 | Wuzhou Syringe, with/Without Needle | Wenzhou Wuzhou Group Co., Ltd. | 2006 | — |
| +2 | K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | 2023 | — |
| +2 | K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K020623 | Duopro Safety Syringe (Duopross)Summary page 2…Materials table. INTENDED USE The DuoProSS Syringes device is intended to be used to inject fluids into, or withdraw fluids from, the body. SUBSTANTIAL EQUIVALENCE K020623 DuoPro Safety Syringe K022806 Modified DuoPro Safety Syringe K031594 1 ml Bak'Snap DuoPro Safety Syringe K034031 10 ml Bak'Snap D… | 2002 |
| * | K022806 | Duopro Safety Syringe (Duopross)Summary page 2…E The DuoProSS Syringes device is intended to be used to inject fluids into, or withdraw fluids from, the body. SUBSTANTIAL EQUIVALENCE K020623 DuoPro Safety Syringe K022806 Modified DuoPro Safety Syringe K031594 1 ml Bak'Snap DuoPro Safety Syringe K034031 10 ml Bak'Snap DuoPro Safety Syringe K980987 B… | 2002 |
| * | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe TraySummary page 2…nded to be used to inject fluids into, or withdraw fluids from, the body. SUBSTANTIAL EQUIVALENCE K020623 DuoPro Safety Syringe K022806 Modified DuoPro Safety Syringe K031594 1 ml Bak'Snap DuoPro Safety Syringe K034031 10 ml Bak'Snap DuoPro Safety Syringe K980987 Becton-Dickinson (BD) Single-Use Hypoder… | 2003 |
| * | K034031 | 10 ML Bak'snap Duopross Retractable Safety SyringeSummary page 2…thdraw fluids from, the body. SUBSTANTIAL EQUIVALENCE K020623 DuoPro Safety Syringe K022806 Modified DuoPro Safety Syringe K031594 1 ml Bak'Snap DuoPro Safety Syringe K034031 10 ml Bak'Snap DuoPro Safety Syringe K980987 Becton-Dickinson (BD) Single-Use Hypodermic and Insulin Syringes and others === Pag… | 2004 |
| * | K980987 | Becton Dickinson SyringeSummary page 2…QUIVALENCE K020623 DuoPro Safety Syringe K022806 Modified DuoPro Safety Syringe K031594 1 ml Bak'Snap DuoPro Safety Syringe K034031 10 ml Bak'Snap DuoPro Safety Syringe K980987 Becton-Dickinson (BD) Single-Use Hypodermic and Insulin Syringes and others DEPARTMENT OF HEALTH & HUMAN SERVICES… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060211 | Wuzhou Syringe, with/Without Needle | 2006 | 3 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K060211 (Wenzhou Wuzhou Group Co., Ltd., 2006) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K020623.
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 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body.
The DuoPross Syringes device is used to inject fluids into,
or withdraw fluids from, the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042500: Duopross Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042500
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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