Cleared Traditional

K852115 - ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER

K852115 is an FDA 510(k) clearance for ARS ENTERPRISES ETHYLENE OXIDE GAS STER..., manufactured by Ars Enterprises, Inc.. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K852115 · Ars Enterprises, Inc. · General Hospital
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Nov 1985
Decision
170d
Days
Class 2
Risk

K852115 is an FDA 510(k) clearance for the ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Ars Enterprises, Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ars Enterprises, Inc. devices

FDA 510(k) Submission Details - K852115

510(k) Number K852115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date November 01, 1985
Days to Decision 170 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 129d · This submission: 170d
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 16
Devices cleared under the same product code (FLF) and FDA review panel - the closest regulatory comparables to K852115.
STERRAD 100 STERILIZATION SYSTEM
K915682 · Johnson & Johnson Medical, Inc. · Oct 1993
MDT/CASTLE 10/90 DUAL LOAD STATION
K920930 · Mdt Corp., Inc. · Mar 1993
STERI-VAC GAS STERILIZER MODEL 5XL
K902036 · 3M Company · Jul 1990
EAGLE 2000 STERILIZER SERIES GAS/AERA
K832945 · Amsco Co. · Oct 1983
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783 · Sybron Corp. · Apr 1982
STERI-VAC #400C GAS STERILIZER
K812867 · 3M Company · Nov 1981