Cleared Traditional

K890764 - LABEL

Also marketed or referenced as:
RADIATION

K890764 is the FDA 510(k) clearance for LABEL by Spsmedical Supply Corp.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K890764 · Spsmedical Supply Corp. · General Hospital
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Aug 1989
Decision
174d
Days
Class 2
Risk

K890764 is an FDA 510(k) clearance for the LABEL, STERILIZATION INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rochester, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 174 days - an extended review 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: 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 Spsmedical Supply Corp. devices

Submission Details

510(k) Number K890764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1989
Decision Date August 07, 1989
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 115
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K890764.
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · American Sterilizer Co. · Sep 1993
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · Edward Weck, Inc. · Feb 1990
TOWER SELF SEAL STERILIZATION POUCH
K895422 · Baxter Healthcare Corp · Nov 1989
DART DAILY AIR REMOVAL TEST
K844512 · American Sterilizer Co. · Mar 1985
STERILIZATION PROCESS INDICATOR
K841168 · Parke-Davis Co. · May 1984
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · American Sterilizer Co. · Nov 1982