Cleared Traditional

K051305 - CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5

K051305 is an FDA 510(k) clearance for CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE..., manufactured by Cs Medical, LLC. The device is a Class 2 General Hospital device with product code PSW cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K051305 · Cs Medical, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2005
Decision
91d
Days
Class 2
Risk

K051305 is an FDA 510(k) clearance for the CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL.... Classified as High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid (product code PSW), Class II - Special Controls.

Submitted by Cs Medical, LLC (Raleigh, US). The FDA issued a Cleared decision on August 18, 2005 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cs Medical, LLC devices

FDA 510(k) Submission Details - K051305

510(k) Number K051305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2005
Decision Date August 18, 2005
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PSW Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

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