Cleared Traditional

K982733 - OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE

K982733 is an FDA 510(k) clearance for OLYMPUS MH-246R BALLOON SHEATH, manufactured by The Olympus Optical Co.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K982733 · The Olympus Optical Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
84d
Days
Class 2
Risk

K982733 is an FDA 510(k) clearance for the OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 84 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 The Olympus Optical Co. devices

FDA 510(k) Submission Details - K982733

510(k) Number K982733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1998
Decision Date October 28, 1998
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

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 348
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K982733.
VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
K982329 · Endosonics Corp. · Jan 1999
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE
K982323 · Olympus America, Inc. · Dec 1998
OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)
K982610 · Olympus Optical, Co. · Nov 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · Olympus America, Inc. · Oct 1998
ULTRA-COVER PU-TRANSDUCER COVER
K981069 · International Medical Products B.V. · Sep 1998
ULTRA IMAGE AND ULTRA SCAN
K981028 · Sonotech, Inc. · Aug 1998