PTI · Non-Coring (Huber) Needle · Chrysalis Intelligence

Device class

Class II

Regulation 880.5570

Total clearances

2021-04-07 → 2026-09-18

Last 12 months

Unique sponsors

Definition

What is Non-Coring (Huber) Needle

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.5570

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
Promisemed Hangzhou Meditech Co., Ltd.	3	0	2025-05-13
Intera Oncology, Inc.	2	0	2022-03-16
Jiangsu Caina Medical Co.,Ltd	1	0	2021-04-07
Martech Medical Products	1	1	2026-09-18
Sb-Kawasumi Laboratories, Inc.	1	1	2025-11-26
Bard Access Systems, Inc.	1	0	2024-11-27

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
A4224	HCPCS	Supplies for maintenance of insulin infusion catheter, per week ✓ CMS-verified description	High	Non-coring Huber needle for access to implanted vascular infusion port

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-18	K254095	Martech Medical Products	25G Huber Needle
2025-11-26	K252355	Sb-Kawasumi Laboratories, Inc.	K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
2025-05-13	K251138	Promisemed Hangzhou Meditech Co., Ltd.	Promisemed Safety Huber Needles
2025-03-14	K243332	Promisemed Hangzhou Meditech Co., Ltd.	Promisemed Safety Huber Needles
2024-11-27	K241353	Bard Access Systems, Inc.	PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
2023-06-08	K230715	Promisemed Hangzhou Meditech Co., Ltd.	Promisemed Safety Huber Needle
2022-03-16	K213823	Intera Oncology, Inc.	Intera Refill Kit
2021-10-14	K211121	Intera Oncology, Inc.	Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
2021-04-07	K200463	Jiangsu Caina Medical Co.,Ltd	Huber Needle Infusion Set, Safety Huber Needle Infusion Set