Cleared Traditional

K931477 - AMERSE

K931477 is an FDA 510(k) clearance for AMERSE, manufactured by Calgon Vestal Div.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K931477 · Calgon Vestal Div. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
450d
Days
Class 1
Risk

K931477 is an FDA 510(k) clearance for the AMERSE. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on June 17, 1994 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6890 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Calgon Vestal Div. devices

FDA 510(k) Submission Details - K931477

510(k) Number K931477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date June 17, 1994
Days to Decision 450 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 129d · This submission: 450d
Pathway characteristics
Predicate-based equivalence.

LRJ Device Classification - Class 1, General Controls

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 16
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K931477.
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
LPH
K931342 · Calgon Vestal Div. · May 1994
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
K931816 · Calgon Vestal Div. · May 1994
VESPHENE II
K931573 · Calgon Vestal Div. · May 1994