Device class
Class II
Regulation 880.5570
Total clearances
3
2021-02-16 → 2024-10-25
Definition
What is Low Dead Space Needle, Single Lumen, Hypodermic
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.
Classification details
Medical specialty
General Hospital
Regulation number
880.5570
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| A4206 |
HCPCS
|
Syringe with needle, sterile, 1 cc or less, each ✓ CMS-verified description |
High
|
Sterile gauze pads/strips, non-impregnated, individually wrapped, by pad or strip |
| A4210 |
HCPCS
|
Needle-free injection device, each ✓ CMS-verified description |
High
|
Needle, sterile, any size |
| A4211 |
HCPCS
|
Supplies for self-administered injections ✓ CMS-verified description |
Medium
|
Supplies for self-administered injections |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-10-25 |
K242956 |
Ocuject, LLC
|
LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle |
| 2024-03-08 |
K231734 |
Tsk Laboratory International Japan KK
|
STERiJECT Low Dead Space, STERiJECT The Invisible Needle |
| 2021-02-16 |
K210444 |
Poonglim Pharmatech, Inc.
|
EZ-Injec LDV Sterile Safety Needle |