Cleared Traditional

K930200 - MULTI DOPPLEX II / FETAL DOPPLEX II (FDA 510(k) Clearance)

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

K930200 · Huntleigh Healthcare, Inc. · Radiology device
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Jun 1994
Decision
526d
Days
Class 2
Risk

K930200 is an FDA 510(k) clearance for the MULTI DOPPLEX II / FETAL DOPPLEX II. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Huntleigh Healthcare, Inc. (Eatontown, US). The FDA issued a Cleared decision on June 24, 1994 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Huntleigh Healthcare, Inc. devices

Submission Details

510(k) Number K930200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date June 24, 1994
Days to Decision 526 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
419d slower than avg
Panel avg: 107d · This submission: 526d
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 Radiology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 59
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