Cleared Traditional

K914784 - PAPILLION PROCTOSCOPE

K914784 is an FDA 510(k) clearance for PAPILLION PROCTOSCOPE, manufactured by Oldelft Corp. of America. The device is a Class 2 Radiology device with product code KQA cleared through the Traditional 510(k) pathway after a 226-day FDA review.

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

FDA 510(k) Submission Details - K914784

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.

KQA Device Classification - Class 2, Special Controls

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.