Cleared Traditional

K982725 - OLYMPUS MH-246R BALLOON SHEATH

K982725 is the FDA 510(k) clearance for OLYMPUS MH-246R BALLOON SHEATH by Olympus America, Inc.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K982725 · Olympus America, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
79d
Days
Class 2
Risk

K982725 is an FDA 510(k) clearance for the OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on October 23, 1998 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Olympus America, Inc. devices

Submission Details

510(k) Number K982725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1998
Decision Date October 23, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 195
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