Cleared Traditional

K233049 - TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233049 · Cs Medical, LLC · General Hospital
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Nov 2023
Decision
57d
Days
Class 2
Risk

K233049 is an FDA 510(k) clearance for the TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant w.... Classified as High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid (product code PSW), Class II - Special Controls.

Submitted by Cs Medical, LLC (Creedmoor, US). The FDA issued a Cleared decision on November 21, 2023 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 892.1570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cs Medical, LLC devices

Submission Details

510(k) Number K233049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date November 21, 2023
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 128d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.