Cleared Traditional

K183444 - Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector

K183444 is an FDA 510(k) clearance for Cenorin 610 Washer-Pasteurizers/High Le..., manufactured by Cenorin, LLC. The device is a Class 2 General Hospital device with product code LDS cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K183444 · Cenorin, LLC · General Hospital
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Sep 2019
Decision
271d
Days
Class 2
Risk

K183444 is an FDA 510(k) clearance for the Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Wash.... Classified as Device, Pasteurization, Hot Water (product code LDS), Class II - Special Controls.

Submitted by Cenorin, LLC (Kent, US). The FDA issued a Cleared decision on September 9, 2019 after a review of 271 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6991 - 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 Cenorin, LLC devices

FDA 510(k) Submission Details - K183444

510(k) Number K183444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2018
Decision Date September 09, 2019
Days to Decision 271 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 129d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDS Device Classification - Class 2, Special Controls

Product Code LDS Device, Pasteurization, Hot Water
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6991
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 - LDS Device, Pasteurization, Hot Water

Devices cleared under the same product code (LDS) and FDA review panel - the closest regulatory comparables to K183444.
RELIANCE FAMILY OF WASHER-DISINFECTORS
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CASTLE 7515 UTENSIL/GLASSWARE WASHER
K844089 · Castle Co. · Jan 1985