Cleared Traditional

K861821 - KEYMED FIBERSCOPE AUTO DISINFECTOR (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861821 · Keymed, Inc. · General Hospital
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Feb 1987
Decision
276d
Days
Class 2
Risk

K861821 is an FDA 510(k) clearance for the KEYMED FIBERSCOPE AUTO DISINFECTOR. Classified as Washer, Cleaner, Automated, Endoscope (product code NVE), Class II - Special Controls.

Submitted by Keymed, Inc. (Essex Ss2 5qh England, GB). The FDA issued a Cleared decision on February 12, 1987 after a review of 276 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 Keymed, Inc. devices

Submission Details

510(k) Number K861821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1986
Decision Date February 12, 1987
Days to Decision 276 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
148d slower than avg
Panel avg: 128d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NVE Washer, Cleaner, Automated, Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition This Automated Device Is Intended To Be Used To Clean Endoscopes. Endoscopes That Are Intended To Be Cleaned By The Automated Cleaner System Should Have Been Pre-cleaned And Tested For Leaks And Lumen Obstructions According To The Instrument Manufacturer's Instructions And Current Professional Practices Prior To Processing In The System. The System Includes A Chemical Dispensing System That Meters Out A Predetermined Volume Of Detergent During The Appropriate Cleaning Cycle. 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). The Instrument Is Placed In A Tray With Each Lumen End Positioned In Opposite Sides Of The Tray To Allow Enough Detergent And Rinsing Water Pass Through The Lumens Of The Endoscopes.
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 - NVE Washer, Cleaner, Automated, Endoscope

All 11
Devices cleared under the same product code (NVE) and FDA review panel - the closest regulatory comparables to K861821.
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
K222849 · Steris · Sep 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
K222543 · Steris · Aug 2022