Cleared Traditional

SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR (K030680) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030680 · Spsmedical Supply Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2003
Decision
65d
Days
Class 2
Risk

K030680 is an FDA 510(k) clearance for the SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rush, US). The FDA issued a Cleared decision on May 9, 2003 after a review of 65 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 Spsmedical Supply Corp. devices

Submission Details

510(k) Number K030680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2003
Decision Date May 09, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 96
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