Cleared Traditional

K970889 - ULTRASOUND TRANSDUCER DRAPE

K970889 is an FDA 510(k) clearance for ULTRASOUND TRANSDUCER DRAPE, manufactured by Protek Medical Products, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K970889 · Protek Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
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Oct 1997
Decision
223d
Days
Class 2
Risk

K970889 is an FDA 510(k) clearance for the ULTRASOUND TRANSDUCER DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Protek Medical Products, Inc. (Iowa City, US). The FDA issued a Cleared decision on October 20, 1997 after a review of 223 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Protek Medical Products, Inc. devices

FDA 510(k) Submission Details - K970889

510(k) Number K970889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1997
Decision Date October 20, 1997
Days to Decision 223 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 129d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 225
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K970889.
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MENTOR SUPER ABSORBENT DRAPE
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OPPORTUNITY, INC. LACERATION TRAY
K971089 · Opportunity, Inc. · Sep 1997
BOUFFANT CAP
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DRAPE, SURGICAL-LATEX
K970891 · Protek Medical Products, Inc. · Aug 1997