Cleared Traditional

K103126 - TROPHON CHEMICAL INDICATOR

K103126 is an FDA 510(k) clearance for TROPHON CHEMICAL INDICATOR, manufactured by Nanosonics Limited. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K103126 · Nanosonics Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
132d
Days
Class 2
Risk

K103126 is an FDA 510(k) clearance for the TROPHON CHEMICAL INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Nanosonics Limited (Alexandria, Nsw, AU). The FDA issued a Cleared decision on March 3, 2011 after a review of 132 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 Nanosonics Limited devices

FDA 510(k) Submission Details - K103126

510(k) Number K103126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2010
Decision Date March 03, 2011
Days to Decision 132 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 129d · This submission: 132d
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 159
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K103126.
STERRAD CHEMICAL INDICATOR STRIP
K103218 · Advanced Sterilization Products · Apr 2011
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K103219 · Advanced Sterilization Products · Apr 2011
VERIFY 270FP CHALLENGE PACK
K103053 · STERIS Corporation · Mar 2011
SMART READ BIOLOGICAL TEST PACK
K103000 · Steritec Products Mfg Co, Inc. · Feb 2011
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