Panels › Gastroenterology, Urology › Product code PNR · Class 2
Enteral Syringes With Enteral Specific Connectors
Regulation 876.5980
2510(k)s in 12 months (34 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in PNR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 4 |
| Covidien | 4 | 0 |
| Neomed, Inc. | 4 | 0 |
| CMT Health PTE., Ltd. | 2 | 0 |
| Jiangsu Caina Medical Co.,Ltd | 2 | 0 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | 2 | 0 |
| Pentaferte Italia S.R.L. | 2 | 0 |
| Shantou Wealy Medical Instrument Co.,Ltd | 2 | 0 |
| Amsino International, Inc. | 1 | 0 |
| Anhui Tiankang Medical Technology Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2026 | K252483 | Enteral Syringe (20ml, 60ml) Chirana T.Injecta,A.S., SK | PNR |
| Apr 8, 2026 | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject EN CMT Health PTE., Ltd., SG | PNR |
| Jul 18, 2025 | K251585 | Profoject Enteral Feeding Syringe CMT Health PTE., Ltd., SG | PNR |
| Dec 19, 2024 | K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Cardinalhealth | PNR |
| Oct 6, 2023 | K231300 | Nutricair Enteral Syringe with ENFit Cair Lgl, FR | PNR |
| Aug 17, 2023 | K222772 | Oral/Enteral Syringe with ENFit connector Anhui Tiankang Medical Technology Co., Ltd., CN | PNR |
| Feb 28, 2022 | K211661 | ENFit enteral syringes (NUTRIFIT) Pentaferte Italia S.R.L., IT | PNR |
| Sep 30, 2021 | K211593 | Enteral Pump Syringe Jiangsu Caina Medical Co.,Ltd, CN | PNR |
| Aug 27, 2021 | K203613 | ENFit Reusable Enteral Syringe Shantou Wealy Medical Instrument Co.,Ltd, CN | PNR |
| Jun 30, 2021 | K211025 | Oral/Enteral Syringe with ENFit connector Ningbo Tianyi Medical Appliance Co., Ltd., CN | PNR |
| Jun 28, 2021 | K203410 | ENFit Disposable Enteral Syringe Shantou Wealy Medical Instrument Co.,Ltd, CN | PNR |
| Apr 28, 2021 | K210621 | Oral/Enteral Syringe Ningbo Tianyi Medical Appliance Co., Ltd., CN | PNR |
| Oct 9, 2020 | K202285 | Medline ENfit OTC Feeding Syringe Medline Industries, Inc. | PNR |
| Sep 28, 2020 | K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) Jiangsu Shenli Medical Production Co., Ltd., CN | PNR |
| Sep 12, 2020 | K193657 | Disposable Enteral Feeding Syringe with Enfit Connector Shinva Ande Healthcare Apparatus Co., Ltd., CN | PNR |
| Aug 6, 2019 | K190502 | ENFit Oral / Enteral Syringe Jiangsu Caina Medical Co.,Ltd, CN | PNR |
| Apr 30, 2019 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 Neomed, Inc. | PNR |
| Nov 9, 2018 | K182649 | Enteral Feeding Syringes with Enfit Connectors Jiangsu Kangbao Medical Equipment Co., Ltd., CN | PNR |
| Oct 11, 2018 | K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) Jiangsu Micsafe Medical Technology Co., Ltd., CN | PNR |
| Mar 30, 2018 | K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip Amsino International, Inc. | PNR |
| Oct 20, 2017 | K170371 | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DA Intervene Group Limited, GB | PNR |
| Oct 6, 2017 | K170672 | Tamper Evident Cap For use with ENFit Syringes International Medical Industries, Inc. | PNR |
| Mar 22, 2017 | K161979 | ENFit enteral syringe Jiangyin Caina Technology Co., Ltd., CN | PNR |
| Mar 22, 2017 | K161141 | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT Pentaferte Italia S.R.L., IT | PNR |
| Feb 15, 2017 | K161811 | Medela Low Dose Enteral Syringe Medela, Inc. | PNR |
| Nov 22, 2016 | K160855 | U&U Enteral Syringe U&U Medical Technology Co, Ltd., CN | PNR |
| Sep 22, 2016 | K162188 | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) Vr Medical Technology, CN | PNR |
| Sep 1, 2016 | K161963 | Monoject Enteral Syringe with ENFit Connector Covidien | PNR |
| Jun 17, 2016 | K161045 | Monoject Covidien | PNR |
| Jun 17, 2016 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringe Neomed, Inc. | PNR |
| May 12, 2016 | K160419 | Monoject Enteral Feeding Syringe with ENFit Connector Covidien | PNR |
| Dec 17, 2015 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps Neomed, Inc. | PNR |
| Apr 9, 2015 | K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector Neomed, Inc. | PNR |
| Feb 23, 2015 | K142128 | KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR Covidien | PNR |
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