Cleared Traditional

VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 (K984270) - FDA 510(k) Clearance

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

K984270 · Roger L. Goodman, D.D.S., P.C. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
171d
Days
Class 2
Risk

K984270 is an FDA 510(k) clearance for the VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500.... Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Roger L. Goodman, D.D.S., P.C. (Mason, US). The FDA issued a Cleared decision on May 20, 1999 after a review of 171 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 Roger L. Goodman, D.D.S., P.C. devices

Submission Details

510(k) Number K984270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1998
Decision Date May 20, 1999
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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.