Cleared Traditional

K953241 - EXSPOR

K953241 is the FDA 510(k) clearance for EXSPOR by Alcide Corp.. It is a Class 1 Gastroenterology & Urology device (product code LRJ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K953241 · Alcide Corp. · Gastroenterology & Urology device
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Sep 1995
Decision
80d
Days
Class 1
Risk

K953241 is an FDA 510(k) clearance for the EXSPOR. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Alcide Corp. (Redmond, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 880.6890 - the FDA gastroenterology and urology 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 Alcide Corp. devices

Submission Details

510(k) Number K953241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1995
Decision Date September 29, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRJ Disinfectant, Medical Devices
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6890
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 - LRJ Disinfectant, Medical Devices

All 12
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K953241.
COVERAGE HBV
K964749 · Convatec, A Division of E.R. Squibb & Sons · Dec 1996
T.B.Q.
K962739 · Convatec, A Division of E.R. Squibb & Sons · Oct 1996
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K934014 · Biotrol, USA, Inc. · Dec 1995
RENALIN COLD STERILANT
K941439 · Minntech Corp. · Jun 1995
CIDEX PLUS 28 DAY SOLUTION
K923744 · Johnson & Johnson Medical, Inc. · Mar 1994
CIDEX ACTIVATED DIALDEHYDE SOLUTION
K924434 · Johnson & Johnson Medical, Inc. · Mar 1994