Cleared Traditional

K821525 - DESERET UNIVERSAL LUER LOCK

K821525 is the FDA 510(k) clearance for DESERET UNIVERSAL LUER LOCK by Warner-Lambert Co.. It is a Class 1 General & Plastic Surgery device (product code KGZ) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K821525 · Warner-Lambert Co. · General & Plastic Surgery device
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Jun 1982
Decision
33d
Days
Class 1
Risk

K821525 is an FDA 510(k) clearance for the DESERET UNIVERSAL LUER LOCK. Classified as Accessories, Catheter (product code KGZ), Class I - General Controls.

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1982 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 K821525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1982
Decision Date June 23, 1982
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGZ Accessories, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - KGZ Accessories, Catheter

All 10
Devices cleared under the same product code (KGZ) and FDA review panel - the closest regulatory comparables to K821525.
CONCEPT SWITCHING STICK
K873009 · Concept, Inc. · Aug 1987
DESERET OFFSET PRN ADAPTER
K821245 · Warner-Lambert Co. · May 1982
PERI-PATCH GLUE MOLD
K810530 · Quinton, Inc. · Mar 1981
PERI-PATCH PERITONEAL CATHETER EXTENSION
K810531 · Quinton, Inc. · Mar 1981
ARGLE LATEX PENROSE TUBING
K802286 · Sherwood Medical Co. · Oct 1980
ARROW CATHETER CLAMP
K802367 · Arrow Intl., Inc. · Oct 1980