Cleared Traditional

K841331 - OLYMPUS KC-10 MOBILE DISINFEC-STAT

K841331 is an FDA 510(k) clearance for OLYMPUS KC-10 MOBILE DISINFEC-STAT, manufactured by Keymed, Inc.. The device is a Class 2 General Hospital device with product code NZA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K841331 · Keymed, Inc. · General Hospital
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Jul 1984
Decision
108d
Days
Class 2
Risk

K841331 is an FDA 510(k) clearance for the OLYMPUS KC-10 MOBILE DISINFEC-STAT. Classified as Accessories, Germicide, Cleaning, For Endoscopes (product code NZA), Class II - Special Controls.

Submitted by Keymed, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1984 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - 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 Keymed, Inc. devices

FDA 510(k) Submission Details - K841331

510(k) Number K841331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date July 19, 1984
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NZA Device Classification - Class 2, Special Controls

Product Code NZA Accessories, Germicide, Cleaning, For Endoscopes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition High Level Disinfection Of Reusable, Heat-sensitive Devices 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.