Cleared Traditional

K901146 - JOSLYN EO STERILIZER/ EO MODERNIZATION KIT

K901146 is an FDA 510(k) clearance for JOSLYN EO STERILIZER/ EO MODERNIZATION KIT, manufactured by Joslyn Valve Corp.. The device is a Class 2 General Hospital device with product code FLF cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K901146 · Joslyn Valve Corp. · General Hospital
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Mar 1991
Decision
360d
Days
Class 2
Risk

K901146 is an FDA 510(k) clearance for the JOSLYN EO STERILIZER/ EO MODERNIZATION KIT. Classified as Sterilizer, Ethylene-oxide Gas (product code FLF), Class II - Special Controls.

Submitted by Joslyn Valve Corp. (Macedon, US). The FDA issued a Cleared decision on March 7, 1991 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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. Elevated predicate reliance profile. 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 Joslyn Valve Corp. devices

FDA 510(k) Submission Details - K901146

510(k) Number K901146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date March 07, 1991
Days to Decision 360 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
231d slower than avg
Panel avg: 129d · This submission: 360d
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 K901146.
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872 · American Sterilizer Co. · Feb 1994
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