Cleared Traditional

K842999 - VENI-SHIELD

K842999 is an FDA 510(k) clearance for VENI-SHIELD, manufactured by U.S. Mfg. & Management, Inc.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K842999 · U.S. Mfg. & Management, Inc. · General Hospital
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Sep 1984
Decision
56d
Days
Class 1
Risk

K842999 is an FDA 510(k) clearance for the VENI-SHIELD. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by U.S. Mfg. & Management, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1984 after a review of 56 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.

FDA 510(k) Submission Details - K842999

510(k) Number K842999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date September 24, 1984
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

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

All 63
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K842999.
SAFTI-BRACELET
K853418 · Advanced Biosearch Assn. · Sep 1985
SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS
K850503 · Turn Needle Intl., Inc. · Apr 1985
TRENDS LANCET
K843882 · Orange Medical Instruments, Inc. · Nov 1984
ACU-DERM TRANSPARENT IV DRESSING
K842064 · Acme United Corp. · Aug 1984
INTRAVASCULAR CATHETER SECUREMENT DEV
K841487 · Tapemark Co. · Jun 1984
FPP IV SECURE
K840683 · Fpp, Inc. · Mar 1984
K842999 · VENI-SHIELD
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