Enteral Pump Syringe
FDA 510(k) K211593 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK211593
Submission
- Device name
- Enteral Pump Syringe
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- May 24, 2021
- Decision date
- September 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNR – Enteral Syringes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Other 510(k)s with product code PNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252483 | Enteral Syringe (20ml, 60ml)PNR · Traditional | Chirana T.Injecta,A.S. | 07/01/2026SE |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…PNR · Traditional | CMT Health PTE., Ltd. | 04/08/2026SE |
| K251585 | Profoject Enteral Feeding SyringePNR · Traditional | CMT Health PTE., Ltd. | 07/18/2025SE |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with…PNR · Special | Cardinalhealth | 12/19/2024SE |
| K231300 | Nutricair Enteral Syringe with ENFitPNR · Traditional | Cair Lgl | 10/06/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/17/2023SE |
| K211661 | ENFit enteral syringes (NUTRIFIT)PNR · Traditional | Pentaferte Italia S.R.L. | 02/28/2022SE |
| K203613 | ENFit Reusable Enteral SyringePNR · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 08/27/2021SE |
| K211025 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 06/30/2021SE |
| K203410 | ENFit Disposable Enteral SyringePNR · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 06/28/2021SE |
More from Shantou Wealy Medical Instrument 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 |
| 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 |
| K193022 | Retractable Safety Insulin SyringeMEG · Traditional | 07/20/2020SE |
| K193526 | Syringe with safety needle, Safety needleFMF · Traditional | 07/17/2020SE |
Questions and answers
When was Enteral Pump Syringe cleared by the FDA?
Enteral Pump Syringe (K211593) received a 510(k) decision of Substantially Equivalent on September 30, 2021, 129 days after the submission was received.
What is the product code of K211593?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.