Cleared Traditional

K895614 - CIVCO LATEX ULTRASOUND SHEATHS

K895614 is the FDA 510(k) clearance for CIVCO LATEX ULTRASOUND SHEATHS by CIVCO Medical Instruments Co., Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K895614 · CIVCO Medical Instruments Co., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
86d
Days
Class 2
Risk

K895614 is an FDA 510(k) clearance for the CIVCO LATEX ULTRASOUND SHEATHS. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on December 14, 1989 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 K895614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1989
Decision Date December 14, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 409
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K895614.
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K896755 · Ge Medical Systems Information Technologies · May 1990
ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322
K884644 · Hitachi Medical Corp. of America · Apr 1990
BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM
K895645 · Biosound, Inc. · Mar 1990
SIEMENS ENDO-P-PROBE
K894806 · Siemens Medical Solutions USA, Inc. · Oct 1989
DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A
K892386 · Toshiba America Medical Systems, In.C · Sep 1989
ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED
K890275 · Acuson Corp. · Jul 1989