510(k) · Cleared
Cleared10 ML Bak'snap Duopross Retractable Safety Syringe
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 Jan 21, 2004 as substantially equivalent to K022806 (M.K. Meditech Co., Ltd., 2002) after a 23-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.
- Decided
- Jan 21, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000572 (2000). 4 ancestors in all. 6 later devices descend from it, 2 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 deviceK034031 10 ML Bak'snap Duopross Retractable Safety SyringeM.K. Meditech Co., Ltd. · 2004
- 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 · 0 of its ownK222925 Hypodermic Syringes & NeedleLifelong Meditech Private Limited · 2023
- Descendant · 3 generations on · 0 of its ownK222124 Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK210103 Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042500Duopross SyringesDuopross Meditech Corporation · 2005 · cites it directly4descendants
- K060211Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006 · 2 generations on3descendants
- K222925Hypodermic Syringes & NeedleLifelong Meditech Private Limited · 2023 · 3 generations on0descendants
- K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · 3 generations on0descendants
- K210103Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited · 2021 · 3 generations on0descendants
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) | K034031 | 10 ML Bak'snap Duopross Retractable Safety Syringe | M.K. Meditech Co., Ltd. | 2004 | — |
| +1 | K042500 | Duopross Syringes | Duopross Meditech Corporation | 2005 | — |
| +2 | K060211 | Wuzhou Syringe, with/Without Needle | Wenzhou Wuzhou Group Co., Ltd. | 2006 | — |
| +3 | K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | 2023 | — |
| +3 | K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
| +3 | K210103 | Safeway, Lifelong Premium, Lifelong Matrix | Lifelong Meditech Private Limited | 2021 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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 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? (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 |
|---|---|---|---|
| * | K022806 | Duopro Safety Syringe (Duopross)Summary page 1…Piston syringe Hypodermic single lumen needle 3. PREDICATE DEVICES 5 rrl-DuoPro'TM1 Safety Syringe (DuoProSS T M ) (K022806) 4. DEVICE DESCRIPTION The 10 nmL B~ak'Snap DuoProSSTm Retractable Safety Syringe is a sterile, single-use, d… | 2002 |
What descends from it? (6)
2 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 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K042500 (Duopross Meditech Corporation, 2005) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K022806.
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 Bak'Snap DuoProSSTM Retractable Safety Syringe 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/K034031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034031: 10 ML Bak'snap Duopross Retractable Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034031
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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