Cleared Traditional

K983947 - AMERSE 2

K983947 is an FDA 510(k) clearance for AMERSE 2, manufactured by STERIS Corporation. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K983947 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
29d
Days
Class 1
Risk

K983947 is an FDA 510(k) clearance for the AMERSE 2. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by STERIS Corporation (St. Louis, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 29 days - a notably fast clearance cycle.

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: 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 STERIS Corporation devices

FDA 510(k) Submission Details - K983947

510(k) Number K983947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1998
Decision Date December 04, 1998
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 37
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K983947.
CONTROL III ELITE
K992661 · Maril Products, Inc. · Sep 1999
PRO-PORTION CLEANER/DISINFECTANT
K991509 · Sultan Chemists, Inc. · Jul 1999
MICROSTAT 2
K984485 · Chemlink Laboratories, LLC · Jan 1999
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K983869 · Caltech Industries, Inc. · Nov 1998
LOW PH PHENOLIC 256
K983585 · Central Solutions, Inc. · Nov 1998
CITREX HOSPITAL SPRAY DISINFECTANT
K982985 · Caltech Industries, Inc. · Nov 1998