Device class
Class II
Regulation 880.5860
Total clearances
7
2022-09-16 → 2025-08-28
Definition
What is Injection Data Capture Device
An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software.
Classification details
Medical specialty
General Hospital
Regulation number
880.5860
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Biocorp Production
|
4 |
0 |
2025-06-09 |
|
Insulcloud S.L. |
1 |
0 |
2024-08-22 |
|
Eli Lilly and Company |
1 |
0 |
2022-09-16 |
|
Ypsomed AG |
1 |
1 |
2025-08-28 |
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 |
| 99091 |
CPT
|
— |
Medium
|
Collection and interpretation of physiologic monitoring data; applicable if device transmits injection data remotely |
| E1970 |
HCPCS
|
— |
Medium
|
Injection devices and accessories; general category for electronic injection data capture devices |
Pulse
Most recent 510(k) clearances