Cleared Traditional

K812080 - AEGIS I.V. STRIPS (FDA 510(k) Clearance)

Class I General Hospital device.

K812080 · Warner-Lambert Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 128d · This submission: 12d
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.