510(k) · Cleared
ClearedSafeR Syringe and SafeR Sting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roncadelle Operations Srl · MEG Syringe, Antistick
Cleared on Dec 29, 2022 as substantially equivalent to K132120 (Beijing Wantefu Medical Apparatus Co., Ltd., 2013) after a 177-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Dec 29, 2022
- Review
- 177 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980069 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- 2 generations backK023752 BD Integra SyringeBd · 2003 · Recalled
- 1 generation backK132120 WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd. · 2013
- This deviceK221981 SafeR Syringe and SafeR StingRoncadelle Operations Srl · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| −2 | K023752 | BD Integra Syringe | Bd | 2003 | 2 |
| −1 | K132120 | WTF Secura Syringe and Needle | Beijing Wantefu Medical Apparatus Co., Ltd. | 2013 | — |
| 0 (this device) | K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K132120 | WTF Secura Syringe and NeedleSummary page 4…Class II Product Code: MEG, FMI, FMF 3. Predicate Device The SafeR Syringe and SafeR Sting is equivalent to the WTF SECURA SYRINGE AND NEEDLE (K132120), manufactured by BEIJING WANTEFU MEDICAL APPARATUS Co., Ldt..… | 2013 |
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 24 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K132120.
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?
SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs…
Read the full statement (155 words)
SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not intended to come in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221981 · printed Nov 3, 2026
Cite this page
510(k) Report. “K221981: SafeR Syringe and SafeR Sting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K221981
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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