NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
FDA 510(k) K152857 · Neomed, Inc.
510(k) numberK152857
Submission
- Device name
- NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
- Applicant
- Neomed, Inc.
Woodstock, GA, US - Received
- September 30, 2015
- Decision date
- December 17, 2015
- 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 |
| K211593 | Enteral Pump SyringePNR · Traditional | Jiangsu Caina Medical Co.,Ltd | 09/30/2021SE |
| 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 |
More from Ningbo Tianyi Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…PNR · Traditional | 04/30/2019SE |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…PNR · Traditional | 06/17/2016SE |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit ConnectorPNR · Traditional | 04/09/2015SE |
| K122373 | Neomed Oral/Enteral SyringeFMF · Special | 09/20/2012SE |
| K120182 | Neomed Gastrointestinal Tube and AccessoriesKNT · Traditional | 04/19/2012SE |
| K100288 | Neomed Enteral Only Extension SetKNT · Traditional | 08/03/2010SE |
| K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…FMF · Traditional | 03/10/2010SE |
| K082238 | Neomed Polyurethane Feeding TubeFPD · Special | 10/01/2008SE |
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0FOS · Special | 07/21/2008SE |
| K073596 | Neomed Single Lumen Umbilical CatheterFOS · Traditional | 02/22/2008SE |
Questions and answers
When was NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps cleared by the FDA?
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (K152857) received a 510(k) decision of Substantially Equivalent on December 17, 2015, 78 days after the submission was received.
What is the product code of K152857?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.