Device class
Class II
Regulation 892.1570
Total clearances
3
2020-04-01 → 2023-11-21
Definition
What is High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification details
Medical specialty
Radiology
Regulation number
892.1570
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 |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Medium
|
Ultrasound coupling agent and sterilization/disinfection supplies code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2023-11-21 |
K233049 |
Cs Medical, LLC
|
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator |
| 2023-06-07 |
K230381 |
Cs Medical, LLC
|
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator |
| 2020-04-01 |
K192228 |
Cs Medical, LLC
|
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant |