510(k) · Cleared
ClearedBak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray
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 Jun 6, 2003 as substantially equivalent to K020623 (M.K. Meditech Co., Ltd., 2002) and 2 other predicates after a 16-day review. Its family tree reaches back 3 generations to 2000. 15 later devices descend from it.
- Decided
- Jun 6, 2003
- Review
- 16 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000572 (2000). 5 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 2 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 1 generation backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- This deviceK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- Descendant · cites it directly · 8 of its ownK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- Descendant · 2 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
- Descendant · 2 generations on · 3 of its ownK060211 Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006
- Descendant · 3 generations on · 2 of its ownK202570 Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005 · cites it directly8descendants
- K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · 2 generations on5descendants
- K042500Duopross SyringesDuopross Meditech Corporation · 2005 · cites it directly4descendants
- K060211Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006 · 2 generations on3descendants
- K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −2 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −1 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| 0 (this device) | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | M.K. Meditech Co., Ltd. | 2003 | — |
| +1 | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| +2 | 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 | — |
| +2 | K060211 | Wuzhou Syringe, with/Without Needle | Wenzhou Wuzhou Group Co., Ltd. | 2006 | — |
| +3 | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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) | 2002 |
| * | K022806 | Duopro Safety Syringe (Duopross)Summary page 1…Piston syringe Hypodermic single lumen needle 3. PREDICATE DEVICES 0 DuoProTMSafety Syringe (DuoProSSTM)(KO20623 & K022806) 0 SECUREGARDB Retractable Safety Syringe (KO 12121) 4. DEVICE DESCRIPTION The 1 mL Bak’Snap DuoPro… | 2002 |
| * | K012121 | Secureguard Retractable Safety Syringe | 2001 |
What descends from it? (15)
See all 153 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 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K050131 (M.K. Meditech Co., Ltd., 2005) has gone furthest, with 8 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 1 mL Bak'Snap DuoProTM 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/K031594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031594: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031594
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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