Cleared Traditional

K132551 - ZF 720 (FDA 510(k) Clearance)

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

K132551 · Umbel Corporation · General & Plastic Surgery device
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Jun 2014
Decision
320d
Days
Class 2
Risk

K132551 is an FDA 510(k) clearance for the ZF 720. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Umbel Corporation (Diamond Bar, US). The FDA issued a Cleared decision on June 30, 2014 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K132551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2013
Decision Date June 30, 2014
Days to Decision 320 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 114d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FSY Light, Surgical, Ceiling Mounted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 & Plastic Surgery devices follow this clearance model.