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
Cleared
Nov 21, 2023
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator
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
Cs Medical, LLC
General Hospital
114d
Cleared
Apr 01, 2020
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
Cs Medical, LLC
General Hospital
229d
Cleared
Apr 12, 2019
TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
Cs Medical, LLC
General Hospital
179d
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.