Cleared Traditional

K914397 - OXFORD OPTRONIX MPM 3S

K914397 is an FDA 510(k) clearance for OXFORD OPTRONIX MPM 3S, manufactured by Dia-Stron, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FTI cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K914397 · Dia-Stron, Ltd. · Gastroenterology & Urology device
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Nov 1992
Decision
412d
Days
Class 2
Risk

K914397 is an FDA 510(k) clearance for the OXFORD OPTRONIX MPM 3S. Classified as Lamp, Endoscope, Incandescent (product code FTI), Class II - Special Controls.

Submitted by Dia-Stron, Ltd. (Broomall, US). The FDA issued a Cleared decision on November 16, 1992 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Dia-Stron, Ltd. devices

FDA 510(k) Submission Details - K914397

510(k) Number K914397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date November 16, 1992
Days to Decision 412 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 130d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTI Device Classification - Class 2, Special Controls

Product Code FTI Lamp, Endoscope, Incandescent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.