Cleared Traditional

DURHAM (K930927) - FDA 510(k) Clearance

Also marketed or referenced as:
T ADAPTOR EXTENSIONSET W/INJECTION SITE

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

K930927 · Intl. Medical Consultants · General Hospital
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Nov 1993
Decision
253d
Days
Class 2
Risk

K930927 is an FDA 510(k) clearance for the DURHAM. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Intl. Medical Consultants (Washington Crossing, US). The FDA issued a Cleared decision on November 3, 1993 after a review of 253 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 Intl. Medical Consultants devices

Submission Details

510(k) Number K930927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date November 03, 1993
Days to Decision 253 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 129d · This submission: 253d
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 236
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K930927.
CONTROL-A-FLO(TM) REGULATOR
K940867 · Baxter Healthcare Corp · May 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326 · Abbott Laboratories · Mar 1994
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362 · Baxter Healthcare Corp · Aug 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058 · C.R. Bard, Inc. · Aug 1993
BAXTER SOLUTION ADMINISTRATION SETS
K924721 · Baxter Healthcare Corp · Jul 1993