510(k) · Cleared
ClearedShina Syringe; Shina Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shina Med Corporation · MEG Syringe, Antistick
Cleared on Oct 27, 2023 as substantially equivalent to K210443 (Poonglim Pharmatech, Inc., 2021) and 1 other predicate after a 185-day review. Its family tree reaches back 9 generations to 1977.
- Decided
- Oct 27, 2023
- Review
- 185 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K771205 (1977). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 5 generations between
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- This deviceK231165 Shina Syringe; Shina Safety SyringeShina Med Corporation · 2023
Show all 9 generations
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 8 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 7 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 6 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 5 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 4 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- This deviceK231165 Shina Syringe; Shina Safety SyringeShina Med Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −8 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −7 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −6 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −5 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −4 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −3 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −2 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| −1 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | — |
| 0 (this device) | K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K210443 | PLPT LDV (Low Dead Volume) Sterile SyringeSummary page 5…21 CFR 880.5570 5) Class of device : Class II 6) Panel : General Hospital 3. The legally marketed device to which we are claiming equivalence K210443, Poonglim Pharmatech Inc. / PLPT LDV (Low Dead Volume) Sterile Syringe K210444, Poonglim Pharmatech Inc. / EZ-Injec LDV Steri… | 2021 |
| * | K210444 | EZ-Injec LDV Sterile Safety NeedleSummary page 5…eral Hospital 3. The legally marketed device to which we are claiming equivalence K210443, Poonglim Pharmatech Inc. / PLPT LDV (Low Dead Volume) Sterile Syringe K210444, Poonglim Pharmatech Inc. / EZ-Injec LDV Sterile safety Needle 4. Device description A sterile device consisting of a calibra… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 46 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 29 ancestors have a recall of any class.
- 4 other devices also cite its predicate K210443.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231165: Shina Syringe; Shina Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231165
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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