Device class
Class II
Regulation 868.5895
Total clearances
4
2025-05-20 → 2026-08-27
Classification details
Medical specialty
Anesthesiology
Regulation number
868.5895
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Breas Medical AB
|
1 |
0 |
2025-05-20 |
|
Convergence Medical Sciences , Ltd. |
1 |
1 |
2026-08-20 |
|
Resmed Corp
|
1 |
1 |
2026-08-27 |
|
CorVent® Medical, Inc. |
1 |
1 |
2026-05-12 |
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 |
| E0606 |
HCPCS
|
Postural drainage board ✓ CMS-verified description |
High
|
Accessories for use with continuous positive airway pressure (CPAP) device |
| E0607 |
HCPCS
|
Home blood glucose monitor ✓ CMS-verified description |
High
|
Home ventilator interface/accessory (exhalation port, valve, etc.); per 1 each |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-27 |
K261360 |
Resmed Corp
|
EasyCare Tx 2 |
| 2026-08-20 |
K253807 |
Convergence Medical Sciences , Ltd.
|
Valence InVent Xtend (CVG-4101-VXA) |
| 2026-05-12 |
K260051 |
CorVent® Medical, Inc.
|
CorVision® (91-205-Z0014) |
| 2025-05-20 |
K242485 |
Breas Medical AB
|
EveryWare |