Cleared Traditional

K812856 - CHEMICAL INDICATORS

K812856 is the FDA 510(k) clearance for CHEMICAL INDICATORS by Sterilization Technical Services, Inc.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K812856 · Sterilization Technical Services, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
24d
Days
Class 2
Risk

K812856 is an FDA 510(k) clearance for the CHEMICAL INDICATORS. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Sterilization Technical Services, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 24 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterilization Technical Services, Inc. devices

Submission Details

510(k) Number K812856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1981
Decision Date November 06, 1981
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 125
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K812856.
STERILIZATION PROCESS INDICATOR
K841168 · Parke-Davis Co. · May 1984
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · American Sterilizer Co. · Nov 1982
PROTECT-O-SEAL
K813014 · Tri-Med, Inc. · Nov 1981
CHEMICAL AUTOCLAVE INDICATOR TAPE
K811936 · American Hospital Supply Corp. · Jul 1981
CASTLE STEAM STERILIZATION INDICATOR
K810614 · Sybron Corp. · Jun 1981
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634 · Organon, Inc. · Dec 1980