510(k) · Cleared
ClearedJeesung Safety Syringe and Single Use Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeesung Medical Co., Ltd. · MEG Syringe, Antistick
Cleared on Aug 18, 2022 as substantially equivalent to K152606 (Jeesung Medical Co., Ltd., 2016) after a 373-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Aug 18, 2022
- Review
- 373 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040545 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK040545 Otter Safety SyringeOtter (China) Technology Co., Ltd. · 2004
- 2 generations backK142435 3S Safety Syringe with/without NeedleSincere Medical Device Co., Ltd. · 2015
- 1 generation backK152606 Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2016
- This deviceK212518 Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040545 | Otter Safety Syringe | Otter (China) Technology Co., Ltd. | 2004 | — |
| −2 | K142435 | 3S Safety Syringe with/without Needle | Sincere Medical Device Co., Ltd. | 2015 | — |
| −1 | K152606 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2016 | — |
| 0 (this device) | K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K152606 | Jeesung Safety Syringe and Single Use NeedlesSummary page 4…n Number: 880.5860 6) Class of device: Class II 7) Panel: General Hospital 3. Predicate Device 1) Trade Name: Jeesung Safety Syringe and Single Use Needles (K152606) 2) Common Name: Syringe, Antistick Piston Syringe 3) Classification Name: Piston Syringe 4) Product Code: MEG 5)… | 2016 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Jeesung safety syringe and single use needles 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/K212518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212518: Jeesung Safety Syringe and Single Use Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212518
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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