NGT · Saline, Vascular Access Flush · Chrysalis Intelligence

Device class

Class II

Regulation 880.5200

Total clearances

2020-02-13 → 2025-12-02

Last 12 months

Unique sponsors

Definition

What is Saline, Vascular Access Flush

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.5200

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
Medxl, Inc.	3	0	2024-02-27
Becton, Dickinson and Company	2	1	2025-12-02
Spm Medicare Pvt. , Ltd.	1	0	2023-11-09
Amsino International, Inc.	1	0	2022-03-22
Pentaferte Italia S.R.L.	1	0	2022-07-20
Hantech Medical Device Co., Ltd.	1	0	2023-09-27
Anhui Tianyang Pharmaceutical Co., Ltd.	1	0	2023-08-12
Anhui Tiankang Medical Technology Co., Ltd.	1	0	2023-08-12
Nurse Assist, LLC	1	0	2020-08-11

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
A4218	HCPCS	Sterile saline or water, metered dose dispenser, 10 ml ✓ CMS-verified description	High	Sterile saline/water, small volume (flush) syringe for vascular catheter patency

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-12-02	K250884	Becton, Dickinson and Company	0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
2024-02-27	K233623	Medxl, Inc.	Praxiject SP 0.9% NaCl
2023-11-09	K231724	Spm Medicare Pvt. , Ltd.	Flush Syringe (Prefilled 0.9% normal saline solution)
2023-09-27	K231363	Hantech Medical Device Co., Ltd.	Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
2023-08-12	K230756	Anhui Tiankang Medical Technology Co., Ltd.	TK Pre-Filled Normal Saline Flush Syringe
2023-08-12	K223584	Anhui Tianyang Pharmaceutical Co., Ltd.	Pre-Filled Normal Saline Flush Syringe
2023-07-21	K231161	Becton, Dickinson and Company	0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe
2023-07-13	K231754	Medxl, Inc.	Praxiject 0.9% NaCl
2022-07-20	K214080	Pentaferte Italia S.R.L.	Pentaflush
2022-03-22	K213522	Amsino International, Inc.	AMSafe Pre-Filled Normal Saline Flush Syringe
2020-08-11	K201286	Nurse Assist, LLC	0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
2020-02-13	K192414	Medxl, Inc.	Praxiject 0.9% NaCl