DR Safety Syringe, Sterile Hypodermic needle for Single use
FDA 510(k) K212226 · Zhuhai DR Medical Instruments Co., Ltd.
510(k) numberK212226
Submission
- Device name
- DR Safety Syringe, Sterile Hypodermic needle for Single use
- Applicant
- Zhuhai DR Medical Instruments Co., Ltd.
Zhuhai, CN - Received
- July 16, 2021
- Decision date
- September 29, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- MEG – Syringe, Antistick
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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|---|---|---|---|
| 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 |
|---|---|---|
| K251788 | Extension tubeDXT · Traditional | 03/05/2026SE |
Questions and answers
When was DR Safety Syringe, Sterile Hypodermic needle for Single use cleared by the FDA?
DR Safety Syringe, Sterile Hypodermic needle for Single use (K212226) received a 510(k) decision of Substantially Equivalent on September 29, 2021, 75 days after the submission was received.
What is the product code of K212226?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.