Cleared Traditional

K925412 - ELECTROMEDICS TISSUE TRAP/ #TT280

K925412 is an FDA 510(k) clearance for ELECTROMEDICS TISSUE TRAP/ #TT280, manufactured by Electromedics, Inc.. The device is a Class 2 General Hospital device with product code BYZ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K925412 · Electromedics, Inc. · General Hospital
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Feb 1993
Decision
102d
Days
Class 2
Risk

K925412 is an FDA 510(k) clearance for the ELECTROMEDICS TISSUE TRAP/ #TT280. Classified as Trap, Sterile Specimen (product code BYZ), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Electromedics, Inc. devices

FDA 510(k) Submission Details - K925412

510(k) Number K925412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1992
Decision Date February 05, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYZ Device Classification - Class 2, Special Controls

Product Code BYZ Trap, Sterile Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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.