Cleared Traditional

I.V. DRESSING (K854040) - FDA 510(k) Clearance

Class I General Hospital device.

K854040 · Consolidated Medical Equipment, Inc. · General Hospital
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Jan 1986
Decision
99d
Days
Class 1
Risk

K854040 is an FDA 510(k) clearance for the I.V. DRESSING. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Consolidated Medical Equipment, Inc. (Utica, US). The FDA issued a Cleared decision on January 9, 1986 after a review of 99 days - within the typical 510(k) review window.

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: 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 Consolidated Medical Equipment, Inc. devices

Submission Details

510(k) Number K854040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1985
Decision Date January 09, 1986
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 K854040.
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
K180994 · Interrad Medical, Inc. · Jul 2019
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