Cleared Traditional

K875193 - INDISTRIP (STERILIZATION PROCESS INDICATOR)

K875193 is an FDA 510(k) clearance for INDISTRIP (STERILIZATION PROCESS INDICATOR), manufactured by Indilab, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K875193 · Indilab, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
105d
Days
Class 2
Risk

K875193 is an FDA 510(k) clearance for the INDISTRIP (STERILIZATION PROCESS INDICATOR). Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Indilab, Inc. (Lyons, US). The FDA issued a Cleared decision on March 31, 1988 after a review of 105 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 Indilab, Inc. devices

FDA 510(k) Submission Details - K875193

510(k) Number K875193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date March 31, 1988
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 224
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K875193.
LABEL, STERILIZATION INDICATOR
K890763 · Spsmedical Supply Corp. · Aug 1989
LABEL, STERILIZATION INDICATOR
K890764 · Spsmedical Supply Corp. · Aug 1989
STRIP, STERILIZATION INDICATOR
K890765 · Spsmedical Supply Corp. · Aug 1989
BIO-CHALLENGE TEST PAK
K851804 · Propper Mfg. Co., Inc. · Jul 1985
DART DAILY AIR REMOVAL TEST
K844512 · American Sterilizer Co. · Mar 1985
STERILIZATION PROCESS INDICATOR
K841168 · Parke-Davis Co. · May 1984