Cleared Traditional

ESP7 VENOUS IMAGE (K982612) - FDA 510(k) Clearance

Class I General Hospital device.

K982612 · Ironmaster, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
140d
Days
Class 1
Risk

K982612 is an FDA 510(k) clearance for the ESP7 VENOUS IMAGE. Classified as Device, Vein Location, Liquid Crystal (product code KZA), Class I - General Controls.

Submitted by Ironmaster, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 14, 1998 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6970 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ironmaster, Inc. devices

Submission Details

510(k) Number K982612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date December 14, 1998
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZA Device, Vein Location, Liquid Crystal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6970
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.