Cleared Traditional

K902977 - K3 COMPUTER SYSTEMS

K902977 is an FDA 510(k) clearance for K3 COMPUTER SYSTEMS, manufactured by Donald L. King M.D.. The device is a Class 2 Radiology device with product code DPT cleared through the Traditional 510(k) pathway after a 662-day FDA review.

K902977 · Donald L. King M.D. · Radiology device
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Apr 1992
Decision
662d
Days
Class 2
Risk

K902977 is an FDA 510(k) clearance for the K3 COMPUTER SYSTEMS. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Donald L. King M.D. (Darien, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 662 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2120 - 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 Donald L. King M.D. devices

FDA 510(k) Submission Details - K902977

510(k) Number K902977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1990
Decision Date April 28, 1992
Days to Decision 662 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
555d slower than avg
Panel avg: 107d · This submission: 662d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 37
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