510(k) Report

FDA product code · General hospital

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

PSWClass II21 CFR 892.1570510(k) required7 decisions since 20050 recalls

7 FDA decisions since 2005. 510(k) reviews decided 2021–2025 took a median of 86 days (half between 71 and 100). No recall names this code. The most-cited predicate is K051305, named by 3 later devices.

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).

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of PSW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PSW

2in 2023

2015: 12016: 12019: 12020: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSW

Too few PSW 510(k)s in any year since 2007 to give a median.

Recalls per year · PSW

No recall names PSW since 2007.

Adverse event reports per year · PSW

No MAUDE report names PSW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20161—00
20170—00
20180—00
20191—00
20201—00
20210—00
20220—00
20232—00
20240—00
20250—00
20260—0—
FIG. 1 — PSW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PSW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PSW devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant…Cs Medical, LLC · 20053cite it
  • K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level…Cs Medical, LLC · 20161cites it
  • K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High…Cs Medical, LLC · 20191cites it
  • K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe ReprocessorPci Medical, Inc. · 20151cites it
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 20201cites it

Which PSW devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLC · 20236generations
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 20205generations
  • K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level…Cs Medical, LLC · 20164generations
  • K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe ReprocessorPci Medical, Inc. · 20152generations
  • K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and…Cs Medical, LLC · 20231generation
  • K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant…Cs Medical, LLC · 20051generation

What has FDA decided in PSW lately?

  • K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLC · 2023
  • K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and…Cs Medical, LLC · 2023
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 2020
  • K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High…Cs Medical, LLC · 2019
  • K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level…Cs Medical, LLC · 2016
  • K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe ReprocessorPci Medical, Inc. · 2015

All 7 PSW decisions →

Related product codes

Other codes under 21 CFR 892.1570.

OQQ Diagnostic Ultrasonic Transducer, RoboticMUI Media, Coupling, UltrasoundITX Transducer, Ultrasonic, DiagnosticOUJ High Level Disinfection Reprocessing…