Cleared Traditional

K921179 - OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20

K921179 is an FDA 510(k) clearance for OLYMPUS-KEYMED DISINFECTANT FUME EXTRAC..., manufactured by Keymed, Inc.. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K921179 · Keymed, Inc. · General Hospital
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Mar 1993
Decision
385d
Days
Class 2
Risk

K921179 is an FDA 510(k) clearance for the OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Keymed, Inc. (Essex Ss2 5qh England, GB). The FDA issued a Cleared decision on March 29, 1993 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K921179

510(k) Number K921179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date March 29, 1993
Days to Decision 385 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
256d slower than avg
Panel avg: 129d · This submission: 385d
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 43
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K921179.
HOBBS MEDICAL CLEANING BRUSH
K933354 · Hobbs Medical, Inc. · Oct 1993
CANDELA MINIBRUSH
K932930 · Candela Laser Corp. · Oct 1993
FLEXIBLE URETERONEPHROSOCOPE
K924135 · Applied Medical Resources · Apr 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