Cleared Traditional

MODEL 6/60 CRT VIDEO-SONAR (K760888) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760888 · Vexilar, Inc. · Obstetrics & Gynecology device
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Feb 1977
Decision
98d
Days
Class 2
Risk

K760888 is an FDA 510(k) clearance for the MODEL 6/60 CRT VIDEO-SONAR. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Vexilar, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1977 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vexilar, Inc. devices

Submission Details

510(k) Number K760888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1976
Decision Date February 01, 1977
Days to Decision 98 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 160d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K760888.
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