Cleared Traditional

K182891 - TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants (FDA 510(k) Clearance)

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

K182891 · Cs Medical, LLC · General Hospital
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Apr 2019
Decision
179d
Days
Class 2
Risk

K182891 is an FDA 510(k) clearance for the TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner a.... 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 April 12, 2019 after a review of 179 days - an extended review 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: 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

Submission Details

510(k) Number K182891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2018
Decision Date April 12, 2019
Days to Decision 179 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
51d slower than avg
Panel avg: 128d · This submission: 179d
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.

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

Devices cleared under the same product code (PSW) and FDA review panel - the closest regulatory comparables to K182891.
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator
K233049 · Cs Medical, LLC · Nov 2023
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
K230381 · Cs Medical, LLC · Jun 2023