Cleared Traditional

K900882 - MULTI DOPPLEX

K900882 is an FDA 510(k) clearance for MULTI DOPPLEX, manufactured by Huntleigh Technology, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K900882 · Huntleigh Technology, Inc. · Radiology device
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Aug 1990
Decision
177d
Days
Class 2
Risk

K900882 is an FDA 510(k) clearance for the MULTI DOPPLEX, MD-1. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Huntleigh Technology, Inc. (Manalapan, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 177 days - an extended review cycle.

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. 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 - K900882

510(k) Number K900882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1990
Decision Date August 22, 1990
Days to Decision 177 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 107d · This submission: 177d
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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