Cleared Traditional

K102217 - SYSTEM 1E CHEMICAL INDICATOR

K102217 is an FDA 510(k) clearance for SYSTEM 1E CHEMICAL INDICATOR, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K102217 · STERIS Corporation · General Hospital
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Nov 2010
Decision
108d
Days
Class 2
Risk

K102217 is an FDA 510(k) clearance for the SYSTEM 1E CHEMICAL INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on November 22, 2010 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 STERIS Corporation devices

FDA 510(k) Submission Details - K102217

510(k) Number K102217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2010
Decision Date November 22, 2010
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - JOJ Indicator, Physical/chemical Sterilization Process

All 212
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K102217.
SMART READ BIOLOGICAL TEST PACK
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VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)
K102296 · STERIS Corporation · Feb 2011
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
K102363 · Spsmedical Supply Corp. · Jan 2011
3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
K101528 · 3M Company · Oct 2010
STERIGAGE MODEL 1243RA, 1243RB, 1243RE
K101249 · 3M Company · Sep 2010
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
K092346 · Serim Research Corp. · Jan 2010