Cleared Traditional

K013721 - SYNTHETIC POLYSIOPRENE ULTRASOUND TRANS...

K013721 is the FDA 510(k) clearance for SYNTHETIC POLYSIOPRENE ULTRASOUND TRANS... by CIVCO Medical Instruments Co., Inc.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K013721 · CIVCO Medical Instruments Co., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
49d
Days
Class 2
Risk

K013721 is an FDA 510(k) clearance for the SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on December 28, 2001 after a review of 49 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 CIVCO Medical Instruments Co., Inc. devices

Submission Details

510(k) Number K013721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2001
Decision Date December 28, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
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 K013721.
EG-3630UR
K041395 · Pentax Precision Instrument Corp. · Jun 2004
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K041396 · Pentax Precision Instrument Corp. · Jun 2004
EG-3830UT
K041397 · Pentax Precision Instrument Corp. · Jun 2004
ULTRASOUND TRANSDUCER COVER
K011265 · Advance Medical Designs, Inc. · Oct 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
K011314 · Aloka Co., Ltd. · May 2001
ALOKA UST-5280-5
K002784 · Aloka Co., Ltd. · Sep 2000