Cleared Traditional

DESARA MINI (K103418) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103418 · Caldera Medical, Inc. · Gastroenterology & Urology device
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Nov 2011
Decision
373d
Days
Class 2
Risk

K103418 is an FDA 510(k) clearance for the DESARA MINI. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (product code PAH), Class II - Special Controls.

Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on November 30, 2011 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Caldera Medical, Inc. devices

Submission Details

510(k) Number K103418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date November 30, 2011
Days to Decision 373 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 130d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

All 19
Devices cleared under the same product code (PAH) and FDA review panel - the closest regulatory comparables to K103418.
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