Cleared Traditional

K914784 - PAPILLION PROCTOSCOPE (FDA 510(k) Clearance)

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

K914784 · Oldelft Corp. of America · Radiology device
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Jun 1992
Decision
226d
Days
Class 2
Risk

K914784 is an FDA 510(k) clearance for the PAPILLION PROCTOSCOPE. Classified as Device, Beam Limiting, X-ray, Therapeutic (product code KQA), Class II - Special Controls.

Submitted by Oldelft Corp. of America (Fairfax, US). The FDA issued a Cleared decision on June 5, 1992 after a review of 226 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oldelft Corp. of America devices

Submission Details

510(k) Number K914784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date June 05, 1992
Days to Decision 226 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 107d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KQA Device, Beam Limiting, X-ray, Therapeutic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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.