510(k) · Cleared
ClearedDuopro Safety Syringe (Duopross)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.K. Meditech Co., Ltd. · MEG Syringe, Antistick
Cleared on May 2, 2002 as substantially equivalent to K003348 (Ensi-Med International Pty., Ltd., 2001) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 2000. 25 later devices descend from it.
- Decided
- May 2, 2002
- Review
- 65 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000572 (2000). 2 ancestors in all. 25 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- This deviceK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- Descendant · cites it directly · 24 of its ownK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- Descendant · cites it directly · 15 of its ownK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- Descendant · 2 generations on · 8 of its ownK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- Descendant · 2 generations on · 6 of its ownK034031 10 ML Bak'snap Duopross Retractable Safety SyringeM.K. Meditech Co., Ltd. · 2004
- Descendant · 3 generations on · 5 of its ownK152808 U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K022806Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002 · cites it directly24descendants
- K031594Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe TrayM.K. Meditech Co., Ltd. · 2003 · cites it directly15descendants
- K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005 · 2 generations on8descendants
- K03403110 ML Bak'snap Duopross Retractable Safety SyringeM.K. Meditech Co., Ltd. · 2004 · 2 generations on6descendants
- K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| 0 (this device) | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| +1 | 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 | — |
| +2 | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| +2 | K034031 | 10 ML Bak'snap Duopross Retractable Safety Syringe | M.K. Meditech Co., Ltd. | 2004 | — |
| +3 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 MEG? 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 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 |
|---|---|---|---|
| * | K003348 | E.N.S.I. Retractable Safety SyringeSummary page 1…Hypodermic Syringe (with or without needle) Classification Name: Piston syringe Hypodermic single lumen needle PREDICATE DEVICE e E.N.S.I Retractable Safety Syringe (K003348, K000572) DEVICE DESCRIPTION The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manua… | 2001 |
| * | K000572 | E.N.S.I. SyringeSummary page 1…c Syringe (with or without needle) Classification Name: Piston syringe Hypodermic single lumen needle PREDICATE DEVICE e E.N.S.I Retractable Safety Syringe (K003348, K000572) DEVICE DESCRIPTION The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retrac… | 2000 |
What descends from it? (25)
See all 254 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?
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020623: Duopro Safety Syringe (Duopross).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020623
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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