PSW · Class II · 21 CFR 892.1570

FDA Product Code PSW: 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).

Leading manufacturers include Cs Medical, LLC.

7
Total
7
Cleared
164d
Avg days
2005
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid Devices (Product Code PSW)

7 devices
1–7 of 7
Cleared Nov 21, 2023
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator
K233049
Cs Medical, LLC
General Hospital · 57d
Cleared Jun 07, 2023
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
K230381
Cs Medical, LLC
General Hospital · 114d

About Product Code PSW - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code PSW since 2005, with 7 receiving FDA clearance (average review time: 164 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

PSW devices are reviewed by the General Hospital panel. Browse all General Hospital devices →