Cleared Traditional

K912925 - ULTRA PVD

K912925 is an FDA 510(k) clearance for ULTRA PVD, manufactured by Advanced Medical Products, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K912925 · Advanced Medical Products, Inc. · Radiology device
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Jun 1992
Decision
351d
Days
Class 2
Risk

K912925 is an FDA 510(k) clearance for the ULTRA PVD. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Advanced Medical Products, Inc. (Washington, US). The FDA issued a Cleared decision on June 18, 1992 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Medical Products, Inc. devices

FDA 510(k) Submission Details - K912925

510(k) Number K912925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1991
Decision Date June 18, 1992
Days to Decision 351 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
244d slower than avg
Panel avg: 107d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 - JAF Monitor, Ultrasonic, Nonfetal

All 7
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