Cleared Traditional

K133724 - MINNCARE HD

K133724 is an FDA 510(k) clearance for MINNCARE HD, manufactured by Medivators, Inc.. The device is a Class 2 General Hospital device with product code NIH cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K133724 · Medivators, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
264d
Days
Class 2
Risk

K133724 is an FDA 510(k) clearance for the MINNCARE HD. Classified as Disinfectant, Subsystem, Water Purification (product code NIH), Class II - Special Controls.

Submitted by Medivators, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 27, 2014 after a review of 264 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.5665 - 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 Medivators, Inc. devices

FDA 510(k) Submission Details - K133724

510(k) Number K133724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2013
Decision Date August 27, 2014
Days to Decision 264 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
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NIH Device Classification - Class 2, Special Controls

Product Code NIH Disinfectant, Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
Definition Disinfectant Intended For Reprocessing Water Purification Systems For Hemodialysis.
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.