510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192228Substantially Equivalent

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

CS Medical LLC, Creedmoor NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192228 is the FDA 510(k) clearance record for CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant, a class II device, cleared for Cs Medical, LLC on under FDA product code PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid). FDA's definition for product code PSW 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...". FDA records list 8 510(k) clearances for Cs Medical, LLC, from to . As of , FDA records show no recalls naming K192228.

Clearance record

Decision date
Received
(229 days to decision)
Product code
PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Cs Medical, LLC 2179 E. Lyon Station Rd., Creedmoor NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSW

Trailing 12 months

FDA records hold no clearances under product code PSW in the trailing twelve months.

FDA records show no clearances under product code PSW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PSW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260