Cleared Traditional

K121280 - MYOSURE INTRUMENT TRAY

K121280 is the FDA 510(k) clearance for MYOSURE INTRUMENT TRAY by Hologic, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K121280 · Hologic, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2013
Decision
284d
Days
Class 2
Risk

K121280 is an FDA 510(k) clearance for the MYOSURE INTRUMENT TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on February 8, 2013 after a review of 284 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Hologic, Inc. devices

Submission Details

510(k) Number K121280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2012
Decision Date February 08, 2013
Days to Decision 284 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 129d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 145
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K121280.
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