Device class
Class II
Regulation 868.5750
Total clearances
8
2020-02-24 → 2026-08-13
Classification details
Medical specialty
Anesthesiology
Regulation number
868.5750
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Aw Technologies Aps |
2 |
1 |
2026-08-13 |
|
Hospitech Respiration , Ltd. |
1 |
0 |
2022-12-29 |
|
Kal-Med, LLC |
1 |
0 |
2020-02-24 |
|
Idmed |
1 |
0 |
2025-08-12 |
|
Biovo Technologies , Ltd. |
1 |
0 |
2020-08-13 |
|
Covidien, LLC
|
1 |
0 |
2021-01-09 |
|
Shanghai Longmann Tech Co., Ltd. |
1 |
0 |
2025-03-07 |
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 |
| 31500 |
CPT
|
— |
Medium
|
Intubation procedure; tracheal tube placement includes cuff management |
| A4630 |
HCPCS
|
Replacement batteries, medically necessary, transcutaneous electrical stimulator, owned by patient ✓ CMS-verified description |
Medium
|
Tracheal tube/endotracheal tube supply code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-13 |
K261499 |
Aw Technologies Aps
|
TrachFlush |
| 2025-08-12 |
K243562 |
Idmed
|
CuffGuard |
| 2025-03-07 |
K242642 |
Shanghai Longmann Tech Co., Ltd.
|
CuffTrek |
| 2023-04-14 |
K220854 |
Aw Technologies Aps
|
TrachCuff Cuff Controller |
| 2022-12-29 |
K221477 |
Hospitech Respiration , Ltd.
|
AG100s |
| 2021-01-09 |
K202874 |
Covidien, LLC
|
Puritan Bennett Cuff Pressure Manager |
| 2020-08-13 |
K192611 |
Biovo Technologies , Ltd.
|
Cuffix |
| 2020-02-24 |
K191858 |
Kal-Med, LLC
|
Pylant Monitor |