Cleared Traditional

K990175 - SHEATHES (NON-LATEX)

K990175 is the FDA 510(k) clearance for SHEATHES (NON-LATEX) by Sheathing Technologies, Inc.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K990175 · Sheathing Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
92d
Days
Class 2
Risk

K990175 is an FDA 510(k) clearance for the SHEATHES (NON-LATEX), STERILE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Sheathing Technologies, Inc. (San Jose, US). The FDA issued a Cleared decision on April 21, 1999 after a review of 92 days - within the typical 510(k) review window.

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 Sheathing Technologies, Inc. devices

Submission Details

510(k) Number K990175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date April 21, 1999
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
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 189
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K990175.
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE
K994069 · Olympus America, Inc. · Jun 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE
K994106 · Olympus America, Inc. · Jun 2000
GE LOGIQ 700
K001016 · GE Medical Systems · Apr 2000
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
K990400 · Hewlett-Packard Co. · Feb 1999
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE
K982323 · Olympus America, Inc. · Dec 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · Olympus America, Inc. · Oct 1998