Cleared Traditional

K063799 - STEAMPLUS STEAM INTEGRATOR

K063799 is an FDA 510(k) clearance for STEAMPLUS STEAM INTEGRATOR, 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 14-day FDA review.

K063799 · Spsmedical Supply Corp. · General Hospital
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Jan 2007
Decision
14d
Days
Class 2
Risk

K063799 is an FDA 510(k) clearance for the STEAMPLUS STEAM INTEGRATOR. 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 January 5, 2007 after a review of 14 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

FDA 510(k) Submission Details - K063799

510(k) Number K063799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date January 05, 2007
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

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 217
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K063799.
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K070461 · STERIS Corporation · Jul 2007
RELIANCE CI PROCESS INDICATOR
K063285 · Albert Browne , Ltd. · Jan 2007
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
K061738 · Albert Browne , Ltd. · Aug 2006
VERIFY DRY HEAT LABEL
K053479 · Albert Browne , Ltd. · Jul 2006
VERIFY 3-10 MIN FLASH INTEGRATOR
K060066 · Albert Browne , Ltd. · Mar 2006

FDA 510(k) Resources - General Hospital

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