Cleared Traditional

K891193 - MEDI-TRACE ACCU-NATE DEVICE

K891193 is an FDA 510(k) clearance for MEDI-TRACE ACCU-NATE DEVICE, manufactured by Graphic Controls Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K891193 · Graphic Controls Corp. · General Hospital
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Sep 1989
Decision
197d
Days
Class 2
Risk

K891193 is an FDA 510(k) clearance for the MEDI-TRACE ACCU-NATE DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on September 19, 1989 after a review of 197 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Graphic Controls Corp. devices

FDA 510(k) Submission Details - K891193

510(k) Number K891193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date September 19, 1989
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 811
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K891193.
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