Cleared Traditional

K820587 - WET PACK LINE OF PRODUCTS

K820587 is the FDA 510(k) clearance for WET PACK LINE OF PRODUCTS by Abco Dealers, Inc.. It is a Class 1 General Hospital device (product code KMJ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K820587 · Abco Dealers, Inc. · General Hospital
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Mar 1982
Decision
22d
Days
Class 1
Risk

K820587 is an FDA 510(k) clearance for the WET PACK LINE OF PRODUCTS. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6375 - 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K820587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1982
Decision Date March 26, 1982
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMJ Lubricant, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
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 - KMJ Lubricant, Patient

All 7
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K820587.
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
STERILE SALINE SOLUTION
K854155 · I M, Inc. · Dec 1985
TOMAC LUBRICATING JELLY
K822143 · American Medical Systems, Inc. · Jul 1982
K-Y LUBRICATING JELLY
K810310 · Johnson & Johnson Professionals, Inc. · Apr 1981
LUBRICATING JELLY
K791243 · Abco Dealers, Inc. · Aug 1979
PRESERVE LUBRICANT CODE NO. 43=4035
K770498 · Codman & Shurtleff, Inc. · Jun 1977