Cleared Traditional

K832945 - EAGLE 2000 STERILIZER SERIES GAS/AERA

K832945 is an FDA 510(k) clearance for EAGLE 2000 STERILIZER SERIES GAS/AERA, manufactured by Amsco Co.. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K832945 · Amsco Co. · General Hospital
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Oct 1983
Decision
50d
Days
Class 2
Risk

K832945 is an FDA 510(k) clearance for the EAGLE 2000 STERILIZER SERIES GAS/AERA. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Amsco Co. (Walker, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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.

FDA 510(k) Submission Details - K832945

510(k) Number K832945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1983
Decision Date October 19, 1983
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLF Device Classification - Class 2, Special Controls

Product Code FLF Sterilizer, Ethylene-oxide Gas
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLF Sterilizer, Ethylene-oxide Gas

All 25
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K832945.
KARLSON OZONE STERILIZER MODEL 100B
K873200 · Life Enhancement Technologies, LLC · Jan 1989
ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER
K852115 · Ars Enterprises, Inc. · Nov 1985
ETHYLENE OXIDE GAS STERILIZA SYS II
K833457 · Ben Venue Laboratories, Inc. · Dec 1983
GAS STERILIZATION EQUIPMENT
K821842 · Getinge International, Inc. · Jul 1982
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783 · Sybron Corp. · Apr 1982
STERI-VAC #400C GAS STERILIZER
K812867 · 3M Company · Nov 1981
K832945 · EAGLE 2000 STERILIZER SERIES GAS/AERA
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