Cleared Traditional

MEDI-TRACE ACCU-NATE DEVICE (K891193) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K891193 · Graphic Controls Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K891193.
IN-LINE VIAL CONNECTION SITE
K900909 · Baxter Healthcare Corp · May 1990
AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
K896161 · 3M Company · Jan 1990
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646 · Baxter Healthcare Corp · Dec 1989
VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
K893716 · Baxter Healthcare Corp · Sep 1989
MODIFIED MATERIAL USED IN INFUSION T
K893909 · Quinton, Inc. · Aug 1989
SURFLO(R) WINGED INFUSION SET
K891063 · Terumo Medical Corp. · Jun 1989