Device class
Class II
Regulation 868.1720
Total clearances
6
2022-03-17 → 2026-07-30
Classification details
Medical specialty
Anesthesiology
Regulation number
868.1720
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Maxtec, LLC |
1 |
0 |
2023-04-01 |
|
Bio-Med Devices, Inc. |
1 |
0 |
2022-03-17 |
|
Careox, LLC |
1 |
0 |
2022-08-19 |
|
Salter Labs |
1 |
1 |
2026-07-30 |
|
Life Spark Medical, LLC |
1 |
0 |
2025-04-24 |
|
Bio-Med Device, Inc. |
1 |
0 |
2025-08-11 |
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 |
| 82375 |
CPT
|
— |
Medium
|
O2 blood gas measurement; device is analyzer but typically billed as part of ABG/VBG panel |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-30 |
K261389 |
Salter Labs
|
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) |
| 2025-08-11 |
K251245 |
Bio-Med Device, Inc.
|
OxyMinder Pro (10310) |
| 2025-04-24 |
K250002 |
Life Spark Medical, LLC
|
Smart Check O2 (MA0236) |
| 2023-04-01 |
K221734 |
Maxtec, LLC
|
Maxtec MaxO2 ME+p |
| 2022-08-19 |
K213933 |
Careox, LLC
|
Percent Oxygen Sensors |
| 2022-03-17 |
K213948 |
Bio-Med Devices, Inc.
|
OxyMinder |