Cleared Traditional

K905735 - GENNY DENNY IV SHIELD

K905735 is the FDA 510(k) clearance for GENNY DENNY IV SHIELD by Tadco, Inc.. It is a Class 1 General Hospital device (product code KMK) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K905735 · Tadco, Inc. · General Hospital
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Jan 1991
Decision
25d
Days
Class 1
Risk

K905735 is an FDA 510(k) clearance for the GENNY DENNY IV SHIELD. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Tadco, Inc. (Farmington, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tadco, Inc. devices

Submission Details

510(k) Number K905735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date January 18, 1991
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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.

Regulatory Peers - KMK Device, Intravascular Catheter Securement

Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K905735.
DUODERM TRANSPARENT HYDROCOLLOID DRESSING
K925992 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
IAB ANCHOR
K922103 · Datascope Corp. · Aug 1993
DESERET POSITIONAL SUTURE WING
K915495 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
ADHESIVE I.V. CATHETER DRESSING
K810579 · Johnson & Johnson Professionals, Inc. · Mar 1981