510(k) · Cleared
ClearedU&U Insulin Syringe with/without Safety Retractable Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&U Medical Technology Co, Ltd. · MEG Syringe, Antistick
Cleared on Mar 25, 2016 as substantially equivalent to K050131 (M.K. Meditech Co., Ltd., 2005) and 1 other predicate after a 179-day review. Its family tree reaches back 5 generations to 2000. 5 later devices descend from it.
- Decided
- Mar 25, 2016
- Review
- 179 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000572 (2000). 33 ancestors in all, the oldest K822083 (1982). 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 4 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 3 generations backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 2 generations backK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- 1 generation backK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- This deviceK152808 U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK202570 Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK220061 Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK230061 Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK191639 TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK193022 Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd · 2020
Most influential descendants
Showing 5 of 5 · See all- K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021 · cites it directly2descendants
- K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023 · 3 generations on0descendants
- K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd. · 2020 · cites it directly0descendants
- K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −4 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −3 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016 | — |
| +1 | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021 | — |
| +2 | K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022 | — |
| +3 | K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023 | — |
| +1 | K191639 | TK Insulin Syringe with/without Saftey Retractable Device | Anhui Tiankang Medical Technology Co., Ltd. | 2020 | — |
| +1 | K193022 | Retractable Safety Insulin Syringe | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K050131 | Insosafe Bak'snap Retractable Insulin Safety SyringeSummary page 4…Traditional Regulation Number: 880.5860 3. Predicate Devices Information: Trade Name: InsoSAFE BakSNAP Retractable Insulin Safety Syringe 510(K) Number: K050131 Company: M.K. Meditech Co., Ltd Trade Name: Disposable Insulin Syringe 510(K) Number: K151949 Company:… | 2005 |
| * | K151949 | Disposable Insulin Syringe Cleared while this submission was under review Summary page 4…ctable Insulin Safety Syringe 510(K) Number: K050131 Company: M.K. Meditech Co., Ltd Trade Name: Disposable Insulin Syringe 510(K) Number: K151949 Company: Jiangyin Caina Technology Co., Ltd. 4. Devices Description: The U&U Insulin Syringe with/without Safety Retr… | 2015 |
What descends from it? (5)
3 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 16 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 33 ancestors have a recall of any class.
- Of its descendants, K202570 (Jiangsu Micsafe Medical Technology Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K050131.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 U&U Insulin Syringe with Safety Retractable Device is a sterile, single use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The U&U Insulin Syringe is a sterile, single use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152808: U&U Insulin Syringe with/without Safety Retractable Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152808
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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