Cleared Traditional

K974301 - CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER

K974301 is an FDA 510(k) clearance for CLK INT'L. SANITARY LATEX PROBE COVER, manufactured by Clk Intl., Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K974301 · Clk Intl., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
81d
Days
Class 2
Risk

K974301 is an FDA 510(k) clearance for the CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Clk Intl., Inc. (New York, US). The FDA issued a Cleared decision on February 6, 1998 after a review of 81 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 Clk Intl., Inc. devices

FDA 510(k) Submission Details - K974301

510(k) Number K974301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date February 06, 1998
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
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 274
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