Cleared Traditional

K030680 - SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR

K030680 is the FDA 510(k) clearance for SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR by Spsmedical Supply Corp.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

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
Combination Product No
PCCP Authorized No
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 Consultant

Entela, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 140
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K030680.
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · Spsmedical Supply Corp. · Jun 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · Advanced Sterilization Products · Apr 2004
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · Advanced Sterilization Products · Oct 2002
STEAMPLUS STERILIZATION TEST
K020409 · Spsmedical Supply Corp. · Jul 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.