Cleared Traditional

K861928 - STERILE O. R. TOWEL

K861928 is an FDA 510(k) clearance for STERILE O. R. TOWEL, manufactured by Anago, Inc.. The device is a Class 2 Radiology device with product code IXX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K861928 · Anago, Inc. · Radiology device
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Jun 1986
Decision
20d
Days
Class 2
Risk

K861928 is an FDA 510(k) clearance for the STERILE O. R. TOWEL. Classified as Processor, Cine Film (product code IXX), Class II - Special Controls.

Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - the FDA radiology and imaging software oversight 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 Anago, Inc. devices

FDA 510(k) Submission Details - K861928

510(k) Number K861928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1986
Decision Date June 09, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXX Device Classification - Class 2, Special Controls

Product Code IXX Processor, Cine Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 Radiology devices follow this clearance model.