Retractable Safety Insulin Syringe
FDA 510(k) K193022 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK193022
Submission
- Device name
- Retractable Safety Insulin Syringe
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- October 30, 2019
- Decision date
- July 20, 2020
- 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
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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 |
|---|---|---|
| K232781 | Safety Sliding Blood Collection SetJKA · Traditional | 03/07/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | 01/18/2024SE |
| K230635 | Pen NeedleFMI · Traditional | 06/02/2023SE |
| K220184 | Pump Alignment SyringeFMF · Traditional | 07/21/2022SE |
| K211593 | Enteral Pump SyringePNR · Traditional | 09/30/2021SE |
| K210217 | Needleless ConnectorFPA · Traditional | 05/17/2021SE |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTI · Traditional | 04/07/2021SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | 02/12/2021SE |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…JKA · Traditional | 09/09/2020SE |
| K193526 | Syringe with safety needle, Safety needleFMF · Traditional | 07/17/2020SE |
Questions and answers
When was Retractable Safety Insulin Syringe cleared by the FDA?
Retractable Safety Insulin Syringe (K193022) received a 510(k) decision of Substantially Equivalent on July 20, 2020, 264 days after the submission was received.
What is the product code of K193022?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.