Cleared Traditional

K890760 - STRIP

K890760 is an FDA 510(k) clearance for STRIP, manufactured by Spsmedical Supply Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K890760 · Spsmedical Supply Corp. · General Hospital
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Aug 1989
Decision
174d
Days
Class 2
Risk

K890760 is an FDA 510(k) clearance for the STRIP, STERILIZATION INDICATOR, E.O. GAS. 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

FDA 510(k) Submission Details - K890760

510(k) Number K890760 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
Combination Product No
PCCP Authorized No
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.

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 142
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K890760.
C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR
K890757 · Spsmedical Supply Corp. · Aug 1989
DRY HEAT STERILIZATION INDICATOR TAPE
K890758 · Spsmedical Supply Corp. · Aug 1989
STRIP, STERILIZATION INDICATOR
K890759 · Spsmedical Supply Corp. · Aug 1989
STRIP, STERILIZATION INDICATOR
K890761 · Spsmedical Supply Corp. · Aug 1989
LABEL, STERILIZATION INDICATOR
K890763 · Spsmedical Supply Corp. · Aug 1989
LABEL, STERILIZATION INDICATOR
K890764 · Spsmedical Supply Corp. · Aug 1989