Cleared Traditional

K052532 - IMAX 9.5 STERILIZERS

K052532 is an FDA 510(k) clearance for IMAX 9.5 STERILIZERS, manufactured by Dental X Srl. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K052532 · Dental X Srl · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
355d
Days
Class 2
Risk

K052532 is an FDA 510(k) clearance for the IMAX 9.5 STERILIZERS. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Dental X Srl (North Attleboro, US). The FDA issued a Cleared decision on September 5, 2006 after a review of 355 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 Dental X Srl devices

FDA 510(k) Submission Details - K052532

510(k) Number K052532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2005
Decision Date September 05, 2006
Days to Decision 355 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
226d slower than avg
Panel avg: 129d · This submission: 355d
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 106
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K052532.
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K023348 · Midmark Corp. · Mar 2003