Device class
Class II
Regulation 868.5800
Total clearances
4
2020-06-01 → 2025-12-29
Classification details
Medical specialty
Anesthesiology
Regulation number
868.5800
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 31603 |
CPT
|
— |
High
|
Tracheostomy tube insertion/change with cuff; device component of procedure |
| A4650 |
HCPCS
|
Implantable radiation dosimeter, each ✓ CMS-verified description |
Medium
|
Tracheostomy tube/cuff supply code for replacement/maintenance |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-12-29 |
K251313 |
Covidien, LLC
|
Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT |
| 2021-11-26 |
K210833 |
Smiths Medical Asd, Inc.
|
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula |
| 2021-08-05 |
K203362 |
Tracoe Medical GmbH
|
TRACOE vario |
| 2020-06-01 |
K193077 |
Covidien
|
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff |