Device class
Class II
Regulation 868.5905
Total clearances
4
2020-11-14 → 2025-07-24
Classification details
Medical specialty
Anesthesiology
Regulation number
868.5905
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Dynasthetics, LLC
|
1 |
0 |
2022-12-15 |
|
Responsive Respiratory |
1 |
0 |
2025-07-24 |
|
Effortless Oxygen, LLC |
1 |
0 |
2022-10-17 |
|
Incoba Ltd D/B/A Dynaris |
1 |
0 |
2020-11-14 |
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 |
| E1406 |
HCPCS
|
Oxygen and water vapor enriching system without heated delivery ✓ CMS-verified description |
High
|
Oxygen and water vapor enriching system with heated delivery |
| E1390 |
HCPCS
|
Oxygen concentrator, single delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate ✓ CMS-verified description |
Medium
|
Oxygen concentrator, stationary or portable; conserver may be ancillary |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-07-24 |
K250322 |
Responsive Respiratory
|
Respond OC Conserving Regulator (130-0800) |
| 2022-12-15 |
K220591 |
Dynasthetics, LLC
|
Proxima |
| 2022-10-17 |
K221014 |
Effortless Oxygen, LLC
|
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile |
| 2020-11-14 |
K200401 |
Incoba Ltd D/B/A Dynaris
|
Apogee |