510(k) · Cleared
ClearedUniqsafe Rotatable, Retractable Safety Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uniqsafe Biomeditech Co., Ltd. · MEG Syringe, Antistick
Cleared on May 9, 2005 as substantially equivalent to K040545 (Otter (China) Technology Co., Ltd., 2004) and 1 other predicate after a 111-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- May 9, 2005
- Review
- 111 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011754 (2003). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011754 | Exel Securetouch PTP Syringe | Exelint Intl. Co. | 2003 | — |
| −1 | K031163 | Sez Safety Syringe | Sez Corporation | 2003 | — |
| 0 (this device) | K050116 | Uniqsafe Rotatable, Retractable Safety Syringes | Uniqsafe Biomeditech Co., Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K040545 | Otter Safety SyringeSummary page 1…ick Syringe 3. Classification: Class II Regulatory Number: 880.5860 Product Code: MEG 4. Predicate Device: * Otter Safety Syringe (K040545) marketed by OTTER (CHINA) TECHNOLOGY CO., LTD.. · SEZ Safety intramu… | 2004 |
| * | K031163 | Sez Safety SyringeSummary page 1…e (K040545) marketed by OTTER (CHINA) TECHNOLOGY CO., LTD.. · SEZ Safety intramuscular/Subcutaneous syringes (K031163) marketed by SEZ CORPORATION. 5. Device Description: The UNIQSAFE Rotatable, Retractable Safet… | 2003 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K040545.
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 UNIQSAFE Rotatable, Retractable Safety Syringe (lml, 3ml, 5ml, 10ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, -disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050116 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050116: Uniqsafe Rotatable, Retractable Safety Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050116
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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