Cleared Traditional

K840208 - CODE 17-ENDOSCOPE DEODORANT

K840208 is an FDA 510(k) clearance for CODE 17-ENDOSCOPE DEODORANT, manufactured by Knox Laboratories. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K840208 · Knox Laboratories · General Hospital
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Jul 1984
Decision
182d
Days
Class 2
Risk

K840208 is an FDA 510(k) clearance for the CODE 17-ENDOSCOPE DEODORANT. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Knox Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 19, 1984 after a review of 182 days - an extended review cycle.

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 Knox Laboratories devices

FDA 510(k) Submission Details - K840208

510(k) Number K840208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date July 19, 1984
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEB Device Classification - Class 2, Special Controls

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition 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 - FEB Accessories, Cleaning, For Endoscope

All 47
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K840208.
OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20
K921179 · Keymed, Inc. · Mar 1993
CLEANING BRUSH
K924103 · United States Endoscopy Group, Inc. · Nov 1992
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN
K901439 · Telemed Systems, Inc. · Jun 1990
FIBERSCOPE DISINFECTANT IRRIGATOR
K830026 · Keymed, Inc. · Jan 1983
KEY MED LEEDS ENDOSCOPE DISINFECTOR
K820152 · Keymed, Inc. · Jan 1982
KEY-MED FIBRESCOPE DISINFECTION TROLLEY
K810818 · Keymed, Inc. · Apr 1981