PNR · Enteral Syringes With Enteral Specific Connectors

Device class

Class II

Regulation 876.5980

Total clearances

2020-09-12 → 2026-07-01

Last 12 months

Unique sponsors

Definition

What is Enteral Syringes With Enteral Specific Connectors

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.5980

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
CMT Health PTE., Ltd.	2	1	2026-04-08
Shantou Wealy Medical Instrument Co.,Ltd	2	0	2021-08-27
Ningbo Tianyi Medical Appliance Co., Ltd.	2	0	2021-06-30
Cair Lgl	1	0	2023-10-06
Shinva Ande Healthcare Apparatus Co., Ltd.	1	0	2020-09-12
Cardinalhealth	1	0	2024-12-19
Medline Industries, Inc.	1	0	2020-10-09
Jiangsu Shenli Medical Production Co., Ltd.	1	0	2020-09-28
Pentaferte Italia S.R.L.	1	0	2022-02-28
Anhui Tiankang Medical Technology Co., Ltd.	1	0	2023-08-17
Jiangsu Caina Medical Co.,Ltd	1	0	2021-09-30
Chirana T.Injecta,A.S.	1	1	2026-07-01

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
B4081	HCPCS	Nasogastric tubing with stylet ✓ CMS-verified description	High	Enteral feeding tube, syringe type, per box of 10
B4102	HCPCS	Enteral formula, for adults, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit ✓ CMS-verified description	High	Enteral nutrition infusion pump, any type

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-01	K252483	Chirana T.Injecta,A.S.	Enteral Syringe (20ml, 60ml)
2026-04-08	K253268	CMT Health PTE., Ltd.	Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
2025-07-18	K251585	CMT Health PTE., Ltd.	Profoject Enteral Feeding Syringe
2024-12-19	K243652	Cardinalhealth	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)
2023-10-06	K231300	Cair Lgl	Nutricair Enteral Syringe with ENFit
2023-08-17	K222772	Anhui Tiankang Medical Technology Co., Ltd.	Oral/Enteral Syringe with ENFit connector
2022-02-28	K211661	Pentaferte Italia S.R.L.	ENFit enteral syringes (NUTRIFIT)
2021-09-30	K211593	Jiangsu Caina Medical Co.,Ltd	Enteral Pump Syringe
2021-08-27	K203613	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Reusable Enteral Syringe
2021-06-30	K211025	Ningbo Tianyi Medical Appliance Co., Ltd.	Oral/Enteral Syringe with ENFit connector
2021-06-28	K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe
2021-04-28	K210621	Ningbo Tianyi Medical Appliance Co., Ltd.	Oral/Enteral Syringe
2020-10-09	K202285	Medline Industries, Inc.	Medline ENfit OTC Feeding Syringe
2020-09-28	K200557	Jiangsu Shenli Medical Production Co., Ltd.	Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
2020-09-12	K193657	Shinva Ande Healthcare Apparatus Co., Ltd.	Disposable Enteral Feeding Syringe with Enfit Connector