Cleared Traditional

K212370 - Leaderflex Mini and Leaderflex Nano

K212370 is an FDA 510(k) clearance for Leaderflex Mini and Leaderflex Nano, manufactured by Vygon USA. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K212370 · Vygon USA · General Hospital
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Aug 2022
Decision
395d
Days
Class 2
Risk

K212370 is an FDA 510(k) clearance for the Leaderflex Mini and Leaderflex Nano. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Vygon USA (Lansdale Montgomery, US). The FDA issued a Cleared decision on August 29, 2022 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Vygon USA devices

FDA 510(k) Submission Details - K212370

510(k) Number K212370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2021
Decision Date August 29, 2022
Days to Decision 395 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
266d slower than avg
Panel avg: 129d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
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