Cleared Traditional

K140736 - STERISAFE HP TABLE-TOP STEAM STERILIZER

K140736 is an FDA 510(k) clearance for STERISAFE HP TABLE-TOP STEAM STERILIZER, manufactured by Milton E Pedrazzi D.D.S., Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K140736 · Milton E Pedrazzi D.D.S., Inc. · General Hospital
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Jan 2015
Decision
302d
Days
Class 2
Risk

K140736 is an FDA 510(k) clearance for the STERISAFE HP TABLE-TOP STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Milton E Pedrazzi D.D.S., Inc. (San Jose, US). The FDA issued a Cleared decision on January 20, 2015 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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. Elevated predicate reliance profile. 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 Milton E Pedrazzi D.D.S., Inc. devices

FDA 510(k) Submission Details - K140736

510(k) Number K140736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2014
Decision Date January 20, 2015
Days to Decision 302 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 129d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 87
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K140736.
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AMSCO CHIMERON MEDIUM STEAM STERLILZER
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