Cleared Traditional

K011284 - THIN FILM DRESSING FOR ULTRASOUND EXAM

K011284 is an FDA 510(k) clearance for THIN FILM DRESSING FOR ULTRASOUND EXAM, manufactured by Martin E. Wendelken. The device is a Class 2 General & Plastic Surgery device with product code ITX cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K011284 · Martin E. Wendelken · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
54d
Days
Class 2
Risk

K011284 is an FDA 510(k) clearance for the THIN FILM DRESSING FOR ULTRASOUND EXAM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Martin E. Wendelken (Elmwood Park, US). The FDA issued a Cleared decision on June 20, 2001 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1570 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011284

510(k) Number K011284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2001
Decision Date June 20, 2001
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 115d · This submission: 54d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 414
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K011284.
ULTRASOUND TRANSDUCER COVER
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AMERITEK BRACHYTHERAPY TEMPLATE
K011581 · Amertek Medical, Inc. · Jul 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
K011314 · Aloka Co., Ltd. · May 2001
TETRAD TC-C3-ACP
K002193 · Tetrad Corp. · May 2001
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
K010883 · Teratech Corp. · Apr 2001
K011284 · THIN FILM DRESSING FOR ULTRASOUND EXAM
Download PDF FDA Summary Martin E. Wendelken