Device class
Class II
Regulation 868.5925
Total clearances
4
2020-11-20 → 2025-04-04
Classification details
Medical specialty
Anesthesiology
Regulation number
868.5925
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Weinmann Emergency Medical Technology GmbH + Co. KG |
1 |
0 |
2020-11-20 |
|
Vortran Medical Technology 1, Inc. |
1 |
0 |
2021-02-11 |
|
Magnamed Tecnologia Medica S/A |
1 |
0 |
2023-05-24 |
|
Draegerwerk AG & CO Kgaa
|
1 |
0 |
2025-04-04 |
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 |
| 94002 |
CPT
|
— |
High
|
Ventilation assist and management; powered emergency ventilator/resuscitator |
| E0601 |
HCPCS
|
Continuous positive airway pressure (cpap) device ✓ CMS-verified description |
Medium
|
Powered ventilation device DME code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-04-04 |
K242769 |
Draegerwerk AG & CO Kgaa
|
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) |
| 2023-05-24 |
K221634 |
Magnamed Tecnologia Medica S/A
|
Oxymag - Transport and Emergency Ventilator |
| 2021-02-11 |
K202219 |
Vortran Medical Technology 1, Inc.
|
VORTRAN GO2VENT with PEEP Valve |
| 2020-11-20 |
K193191 |
Weinmann Emergency Medical Technology GmbH + Co. KG
|
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag |