PSWClass II

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

21 CFR 892.1570 / Radiology

PSW is the FDA product code for High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid, a class II device type, regulated under 21 CFR 892.1570. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2023-11-21, and no recalls.

Classification record

Product code: PSW
Device name: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
FDA definition: 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).
Regulation: 21 CFR 892.1570
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 0

Clearances, product code PSW

By decision year

7 clearances under product code PSW with a decision year between 2005 and 2023, 2023 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code PSW by decision year
Year	Clearances
2005	1
2015	1
2016	1
2019	1
2020	1
2023	2

Applicants with the most clearances

Product code PSW

Applicants holding the most 510(k) clearances under product code PSW
Applicant	Clearances
CS Medical LLC	6
Pci Medical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code