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 Sep 19, 2002 as substantially equivalent to K020623 (M.K. Meditech Co., Ltd., 2002) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 2000. 24 later devices descend from it.
- Decided
- Sep 19, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000572 (2000). 3 ancestors in all. 24 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 1 generation backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- This deviceK022806 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 · cites it directly · 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
- Descendant · cites it directly · 4 of its ownK042500 Duopross SyringesDuopross Meditech Corporation · 2005
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- 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 · cites it directly6descendants
- K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · 3 generations on5descendants
- K042500Duopross SyringesDuopross Meditech Corporation · 2005 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −1 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
| +1 | K042500 | Duopross Syringes | Duopross Meditech Corporation | 2005 | — |
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 |
|---|---|---|
| 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? (3)
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 1…Name: Piston syringe Hypodermic single lumen needle 3. PREDICATE DEVICES 0 DuoProTMSafety Syringe (DuoProSSTM)(K020623) 0 E.N.S.I. Retractable Safety Syringe (K003348, K000572) 4. DEVICEDESCRIPTION The modified DuoProTMSafety… | 2002 |
| * | K003348 | E.N.S.I. Retractable Safety SyringeSummary page 1…ic single lumen needle 3. PREDICATE DEVICES 0 DuoProTMSafety Syringe (DuoProSSTM)(K020623) 0 E.N.S.I. Retractable Safety Syringe (K003348, K000572) 4. DEVICEDESCRIPTION The modified DuoProTMSafety Syringe (DuoProSSTM)is a sterile, single-use, disp… | 2001 |
| * | K000572 | E.N.S.I. SyringeSummary page 1…lumen needle 3. PREDICATE DEVICES 0 DuoProTMSafety Syringe (DuoProSSTM)(K020623) 0 E.N.S.I. Retractable Safety Syringe (K003348, K000572) 4. DEVICEDESCRIPTION The modified DuoProTMSafety Syringe (DuoProSSTM)is a sterile, single-use, disposable an… | 2000 |
What descends from it? (24)
See all 246 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | 2003 | 15 |
| K034031 | 10 ML Bak'snap Duopross Retractable Safety Syringe | 2004 | 6 |
| K042500 | Duopross Syringes | 2005 | 4 |
| K032747 | Biotop DJT-a Safety Syringe | 2004 | 4 |
| K132557 | Ewnl Safety Syringe with Needle | 2014 | 0 |
| K120641 | Global Medi Products Retractable Safety Syringe | 2012 | 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 2 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K031594 (M.K. Meditech Co., Ltd., 2003) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K020623.
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 intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022806: Duopro Safety Syringe (Duopross).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022806
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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