Cleared Traditional

K812435 - DATAPASS

K812435 is the FDA 510(k) clearance for DATAPASS by General Electric Co.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K812435 · General Electric Co. · Radiology device
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Jan 1982
Decision
156d
Days
Class 2
Risk

K812435 is an FDA 510(k) clearance for the DATAPASS. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 156 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 General Electric Co. devices

Submission Details

510(k) Number K812435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1981
Decision Date January 28, 1982
Days to Decision 156 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
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 408
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K812435.
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K811842 · Siemens Gammasonics, Inc. · Nov 1981
FETAL VITABILITY TM MODE
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LINUS
K812398 · Fischer Imaging Corp. · Nov 1981