Cleared Traditional

K981069 - ULTRA-COVER PU-TRANSDUCER COVER

K981069 is an FDA 510(k) clearance for ULTRA-COVER PU-TRANSDUCER COVER, manufactured by International Medical Products B.V.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K981069 · International Medical Products B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
183d
Days
Class 2
Risk

K981069 is an FDA 510(k) clearance for the ULTRA-COVER PU-TRANSDUCER COVER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by International Medical Products B.V. (Zutphen, NL). The FDA issued a Cleared decision on September 23, 1998 after a review of 183 days - an extended review 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: 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 International Medical Products B.V. devices

FDA 510(k) Submission Details - K981069

510(k) Number K981069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1998
Decision Date September 23, 1998
Days to Decision 183 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 107d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Product Service, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 284
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K981069.
OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)
K982610 · Olympus Optical, Co. · Nov 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
K982733 · The Olympus Optical Co. · Oct 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · Olympus America, Inc. · Oct 1998
ULTRA IMAGE AND ULTRA SCAN
K981028 · Sonotech, Inc. · Aug 1998
EUP-OL334 LAPARASCOPICPROBE
K981434 · Hitachi Medical Corp. of America · Jul 1998
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
K964001 · Med Institute, Inc. · Apr 1998