Device class
—
Regulation —
Total clearances
5
2021-08-26 → 2025-11-24
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Compact Medical, Inc. |
1 |
0 |
2025-04-25 |
|
Xiamen Compower Medical Tech. Co., Ltd. |
1 |
0 |
2021-08-26 |
|
Laerdal Medical AS |
1 |
1 |
2025-11-24 |
|
Safe Bvm Corporation |
1 |
0 |
2022-08-18 |
|
Archeon |
1 |
0 |
2023-03-18 |
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 |
| 94003 |
CPT
|
— |
High
|
Manual ventilation assist; bag-valve-mask/manual resuscitator |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-11-24 |
K251631 |
Laerdal Medical AS
|
The BAG manual resuscitator and accessories |
| 2025-04-25 |
K243861 |
Compact Medical, Inc.
|
butterflyBVM |
| 2023-03-18 |
K221841 |
Archeon
|
EOlife® |
| 2022-08-18 |
K212905 |
Safe Bvm Corporation
|
Sotair Device |
| 2021-08-26 |
K210288 |
Xiamen Compower Medical Tech. Co., Ltd.
|
Disposable Manual Resuscitator |