FDA 510(k) Applications for Medical Device Product Code "PNR"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K171857 | Amsino International, Inc. | AMSure« Enteral Feeding Syringe with ENFit Tip | 03/30/2018 |
| K222772 | Anhui Tiankang Medical Technology Co., Ltd. | Oral/Enteral Syringe with ENFit connector | 08/17/2023 |
| K231300 | Cair LGL | Nutricair Enteral Syringe with ENFit | 10/06/2023 |
| K243652 | Cardinal Health | MonojectÖ Enteral Syringe with ENFit Connector (401SE); MonojectÖ Enteral Syringe with ENFit Connector (403SE); MonojectÖ Enteral Syringe with ENFit Connector (406SE); MonojectÖ Enteral Syringe with ENFit Connector (412SE); MonojectÖ Enteral Syringe with | 12/19/2024 |
| K251585 | CMT Health PTE. Ltd. | ProfojectÖ Enteral Feeding Syringe | 07/18/2025 |
| K142128 | COVIDIEN | KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR | 02/23/2015 |
| K161045 | Covidien | Monoject | 06/17/2016 |
| K160419 | COVIDIEN | Monoject Enteral Feeding Syringe with ENFit Connector | 05/12/2016 |
| K161963 | COVIDIEN | Monoject Enteral Syringe with ENFit Connector | 09/01/2016 |
| K170672 | International Medical Industries, Inc. | Tamper Evident Cap For use with ENFit Syringes | 10/06/2017 |
| K170371 | INTERVENE Group Limited | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe | 10/20/2017 |
| K190502 | Jiangsu Caina Medical Co., Ltd. | ENFit Oral / Enteral Syringe | 08/06/2019 |
| K211593 | Jiangsu Caina Medical Co., Ltd. | Enteral Pump Syringe | 09/30/2021 |
| K222155 | Jiangsu Caina Medical Co., Ltd. | Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector | 09/16/2022 |
| K182649 | Jiangsu Kangbao Medical Equipment Co., Ltd | Enteral Feeding Syringes with Enfit Connectors | 11/09/2018 |
| K181426 | Jiangsu Micsafe Medical Technology Co., Ltd | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | 10/11/2018 |
| K200557 | Jiangsu Shenli Medical Production Co., Ltd | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | 09/28/2020 |
| K161979 | JIANGYIN CAINA TECHNOLOGY CO., LTD. | ENFit enteral syringe | 03/22/2017 |
| K161811 | Medela, Inc. | Medela Low Dose Enteral Syringe | 02/15/2017 |
| K202285 | Medline Industries, Inc. | Medline ENfit OTC Feeding Syringe | 10/09/2020 |
| K161039 | NeoMed, Inc. | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | 06/17/2016 |
| K143344 | NEOMED, INC. | NeoMed NeoConnect Enteral Syringes with ENFit Connector | 04/09/2015 |
| K152857 | NEOMED, INC. | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | 12/17/2015 |
| K183540 | NeoMed, Inc. | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | 04/30/2019 |
| K210621 | Ningbo Tianyi Medical Appliance Co., Ltd. | Oral/Enteral Syringe | 04/28/2021 |
| K211025 | Ningbo Tianyi Medical Appliance Co., Ltd. | Oral/Enteral Syringe with ENFit connector | 06/30/2021 |
| K161141 | PENTAFERTE ITALIA S.R.L. | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT | 03/22/2017 |
| K211661 | Pentaferte Italia S.R.L. | ENFit enteral syringes (NUTRIFIT) | 02/28/2022 |
| K192179 | Shanghai Kindly Enterprise Development Group Co., Ltd | Oral/Enteral Syringe | 05/01/2020 |
| K203410 | Shantou Wealy Medical Instrument Co., Ltd. | ENFit Disposable Enteral Syringe | 06/28/2021 |
| K203613 | Shantou Wealy Medical Instrument Co., Ltd. | ENFit Reusable Enteral Syringe | 08/27/2021 |
| K193657 | Shinva Ande Healthcare Apparatus Co., Ltd. | Disposable Enteral Feeding Syringe with Enfit Connector | 09/12/2020 |
| K160855 | U&U MEDICAL TECHNOLOGY CO.,LTD | U&U Enteral Syringe | 11/22/2016 |
| K162188 | VR MEDICAL TECHNOLOGY | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) | 09/22/2016 |
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