Atlas FDA

PNR

34 FDA 510(k) clearances · Product code

158 daysmedian time to decision
282 days90th percentile
34clearances measured

FDA profile

Official device name
Enteral Syringes With Enteral Specific Connectors
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Medical specialty
Gastroenterology, Urology
FDA definition
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Adverse events (MAUDE)
2024: 34 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Enteral Syringe (20ml, 60ml) (K252483)Chirana T.Injecta,A.S.2026-07-01
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (K253268)CMT Health PTE., Ltd.2026-04-08
Profoject™ Enteral Feeding Syringe (K251585)CMT Health PTE., Ltd.2025-07-18
Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) (K243652)Cardinalhealth2024-12-19
Nutricair Enteral Syringe with ENFit (K231300)Cair Lgl2023-10-06
Oral/Enteral Syringe with ENFit connector (K222772)Anhui Tiankang Medical Technology Co., Ltd.2023-08-17
ENFit enteral syringes (NUTRIFIT) (K211661)Pentaferte Italia S.R.L.2022-02-28
Enteral Pump Syringe (K211593)Jiangsu Caina Medical Co.,Ltd2021-09-30
ENFit Reusable Enteral Syringe (K203613)Shantou Wealy Medical Instrument Co.,Ltd2021-08-27
Oral/Enteral Syringe with ENFit connector (K211025)Ningbo Tianyi Medical Appliance Co., Ltd.2021-06-30
ENFit Disposable Enteral Syringe (K203410)Shantou Wealy Medical Instrument Co.,Ltd2021-06-28
Oral/Enteral Syringe (K210621)Ningbo Tianyi Medical Appliance Co., Ltd.2021-04-28
Medline ENfit OTC Feeding Syringe (K202285)Medline Industries, Inc.2020-10-09
Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) (K200557)Jiangsu Shenli Medical Production Co., Ltd.2020-09-28
Disposable Enteral Feeding Syringe with Enfit Connector (K193657)Shinva Ande Healthcare Apparatus Co., Ltd.2020-09-12
ENFit Oral / Enteral Syringe (K190502)Jiangsu Caina Medical Co.,Ltd2019-08-06
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) (K183540)Neomed, Inc.2019-04-30
Enteral Feeding Syringes with Enfit Connectors (K182649)Jiangsu Kangbao Medical Equipment Co., Ltd.2018-11-09
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) (K181426)Jiangsu Micsafe Medical Technology Co., Ltd.2018-10-11
AMSure® Enteral Feeding Syringe with ENFit Tip (K171857)Amsino International, Inc.2018-03-30
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 (K170371)Intervene Group Limited2017-10-20
Tamper Evident Cap For use with ENFit Syringes (K170672)International Medical Industries, Inc.2017-10-06
ENFit enteral syringe (K161979)Jiangyin Caina Technology Co., Ltd.2017-03-22
ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT (K161141)Pentaferte Italia S.R.L.2017-03-22
Medela Low Dose Enteral Syringe (K161811)Medela, Inc.2017-02-15
U&U Enteral Syringe (K160855)U&U Medical Technology Co, Ltd.2016-11-22
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) (K162188)Vr Medical Technology2016-09-22
Monoject Enteral Syringe with ENFit Connector (K161963)Covidien2016-09-01
Monoject (K161045)Covidien2016-06-17
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) (K161039)Neomed, Inc.2016-06-17
Monoject Enteral Feeding Syringe with ENFit Connector (K160419)Covidien2016-05-12
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (K152857)Neomed, Inc.2015-12-17
NeoMed NeoConnect Enteral Syringes with ENFit Connector (K143344)Neomed, Inc.2015-04-09
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR (K142128)Covidien2015-02-23

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Every clearance here is in the API, with alerts when new ones post.