Device class
Class II
Regulation 868.5690
Total clearances
7
2020-02-19 → 2025-08-21
Classification details
Medical specialty
Anesthesiology
Regulation number
868.5690
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Respinova, Ltd. |
1 |
0 |
2021-03-31 |
|
Enchant Tek Co. , Ltd. |
1 |
0 |
2024-02-02 |
|
Peep Medical, LLC Dba Go2 Devices |
1 |
0 |
2023-06-02 |
|
Tidal Medical Technologies, LLC |
1 |
0 |
2025-08-21 |
|
Lung Trainers, LLC |
1 |
0 |
2023-07-05 |
|
D R Burton Healthcare, LLC |
1 |
0 |
2020-02-19 |
|
Medline Industries, Inc.
|
1 |
0 |
2022-10-25 |
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 |
| 94060 |
CPT
|
— |
High
|
Bronchospirometry; incentive spirometry for therapeutic breathing exercises |
| E0601 |
HCPCS
|
Continuous positive airway pressure (cpap) device ✓ CMS-verified description |
Medium
|
Therapeutic spirometer DME code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-08-21 |
K241152 |
Tidal Medical Technologies, LLC
|
InSee |
| 2024-02-02 |
K233855 |
Enchant Tek Co. , Ltd.
|
AllPEP |
| 2023-07-05 |
K221058 |
Lung Trainers, LLC
|
LungTrainer (MD2 & MD3) |
| 2023-06-02 |
K222018 |
Peep Medical, LLC Dba Go2 Devices
|
Breathe+ |
| 2022-10-25 |
K220565 |
Medline Industries, Inc.
|
Hudson RCI Triflo II Incentive Deep Breathing Exerciser |
| 2021-03-31 |
K203378 |
Respinova, Ltd.
|
Pulsehaler |
| 2020-02-19 |
K192000 |
D R Burton Healthcare, LLC
|
D R Burton OxyPAP |