Chrysalis Intelligence · Product Codes · BTO

BTO · Tube, Tracheostomy (W/Wo Connector)

Anesthesiology · 3 clearances · 3 unique sponsors

Device class
Class II
Regulation 868.5800
Total clearances
3
2020-07-22 → 2025-06-10
Last 12 months
0
Unique sponsors
3
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.5800
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Venner Medical (Singapore) Pte, Ltd. 1 0 2020-07-22
Vitaltec Corporation 1 0 2025-06-10
Teleflex Medical 1 0 2024-03-22
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.

CodeTypeDescriptionConfidenceRationale
A4625 HCPCS Tracheostomy care kit for new tracheostomy ✓ CMS-verified description High Tracheostomy tube supply code
31610 CPT Medium Tracheostomy procedure includes tube placement
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-06-10 K242921 Vitaltec Corporation 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
2024-03-22 K233713 Teleflex Medical Pilling Tracheostomy Tubes
2020-07-22 K192511 Venner Medical (Singapore) Pte, Ltd. Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm