Cleared Traditional

K983947 - AMERSE 2

K983947 is the FDA 510(k) clearance for AMERSE 2 by STERIS Corporation. It is a Class 1 General Hospital device (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

Submission Details

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.

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 9
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K983947.
T.B.Q. RTU
K980369 · STERIS Corporation · Feb 1998
GERMICIDAL CLOTH
K974304 · Convatec, A Division of E.R. Squibb & Sons · Jan 1998
COVERAGE SPRAY HBV
K964835 · Convatec, A Division of E.R. Squibb & Sons · Dec 1996
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