Cleared Traditional

K924516 - OP3/VP4

K924516 is an FDA 510(k) clearance for OP3/VP4, manufactured by Huntleigh Technology, Inc.. The device is a Class 2 Radiology device with product code HGL cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K924516 · Huntleigh Technology, Inc. · Radiology device
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Jun 1993
Decision
297d
Days
Class 2
Risk

K924516 is an FDA 510(k) clearance for the OP3/VP4. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Huntleigh Technology, Inc. (Manalapan, US). The FDA issued a Cleared decision on June 28, 1993 after a review of 297 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2960 - 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. Standard predicate reliance. 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 Huntleigh Technology, Inc. devices

FDA 510(k) Submission Details - K924516

510(k) Number K924516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date June 28, 1993
Days to Decision 297 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 107d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGL Device Classification - Class 2, Special Controls

Product Code HGL Transducer, Ultrasonic, Obstetric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2960
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 - HGL Transducer, Ultrasonic, Obstetric

All 22
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K924516.
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