Cleared Traditional

K812080 - AEGIS I.V. STRIPS

K812080 is an FDA 510(k) clearance for AEGIS I.V. STRIPS, manufactured by Warner-Lambert Co.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K812080 · Warner-Lambert Co. · General Hospital
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Aug 1981
Decision
12d
Days
Class 1
Risk

K812080 is an FDA 510(k) clearance for the AEGIS I.V. STRIPS. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1981 after a review of 12 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 Warner-Lambert Co. devices

FDA 510(k) Submission Details - K812080

510(k) Number K812080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1981
Decision Date August 03, 1981
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
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 13
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K812080.
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770 · Ipax, Inc. · Apr 1987
SAFTI-BRACELET
K853418 · Advanced Biosearch Assn. · Sep 1985
ACU-DERM TRANSPARENT IV DRESSING
K842064 · Acme United Corp. · Aug 1984
ADHESIVE I.V. CATHETER DRESSING
K810579 · Johnson & Johnson Professionals, Inc. · Mar 1981
I.V. LOK TM
K770119 · Jelco Laboratories · Mar 1977