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 and Pci Medical, Inc..

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
Cleared Apr 01, 2020
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
K192228
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
K182891
Cs Medical, LLC
General Hospital · 179d
Cleared Nov 03, 2016
CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
K160921
Cs Medical, LLC
General Hospital · 213d
Cleared Nov 16, 2015
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
K150504
Pci Medical, Inc.
General Hospital · 263d
Cleared Aug 18, 2005
CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
K051305
Cs Medical, LLC
General Hospital · 91d

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.