Disposable Automatically Retractable Insulin Safety Syringe
FDA 510(k) K210216 · Shantou Wealy Medical Instrument Co.,Ltd
510(k) numberK210216
Submission
- Device name
- Disposable Automatically Retractable Insulin Safety Syringe
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
Shantou, CN - Received
- January 27, 2021
- Decision date
- March 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEG – Syringe, Antistick
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code MEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional | Methyl Co., Ltd. | 02/18/2026SE |
| K250847 | VaporShieldMEG · Traditional | Vault Paragon Group, Inc. | 12/12/2025SE |
| K230287 | SaviSafe Safety DeviceMEG · Traditional | Suzhou Savicred Biotechnology Co., Ltd. | 11/21/2023SE |
| K231165 | Shina Syringe; Shina Safety SyringeMEG · Traditional | Shina Med Corporation | 10/27/2023SE |
| K231907 | Medline Safety Insulin and TB SyringesMEG · Traditional | Medline Industries, LP | 10/18/2023SE |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | Cardinal Health200, LLC | 06/21/2023SE |
| K220114 | PowerPAK SyringeMEG · Traditional | Vault Paragon Group, Inc. | 01/25/2023SE |
| K221981 | SafeR Syringe and SafeR StingMEG · Traditional | Roncadelle Operations Srl | 12/29/2022SE |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 11/23/2022SE |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/01/2022SE |
More from Jiangsu Kangbao Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | 11/23/2022SE |
| K203613 | ENFit Reusable Enteral SyringePNR · Traditional | 08/27/2021SE |
| K203410 | ENFit Disposable Enteral SyringePNR · Traditional | 06/28/2021SE |
| K141640 | Automatically Retractable Safety Syringes with Fixed NeedleMEG · Traditional | 11/19/2014SE |
| K113587 | Automatically Retractable Safety Syringe (with Fixed Needle)MEG · Traditional | 02/24/2012SE |
Questions and answers
When was Disposable Automatically Retractable Insulin Safety Syringe cleared by the FDA?
Disposable Automatically Retractable Insulin Safety Syringe (K210216) received a 510(k) decision of Substantially Equivalent on March 4, 2022, 401 days after the submission was received.
What is the product code of K210216?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.