Cleared Traditional

K860246 - ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE (FDA 510(k) Clearance)

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

K860246 · Buckman Co., Inc. · General Hospital
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Apr 1986
Decision
68d
Days
Class 2
Risk

K860246 is an FDA 510(k) clearance for the ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE. Classified as Endoscope Maintenance System (product code PUP), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on April 2, 1986 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Buckman Co., Inc. devices

Submission Details

510(k) Number K860246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1986
Decision Date April 02, 1986
Days to Decision 68 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
60d faster than avg
Panel avg: 128d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PUP Endoscope Maintenance System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Assist In Disinfecting, Rinsing And Storing Endoscopes Or Similar Elongated Instruments.
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.