Cleared Traditional

K132069 - DESARA MESH, DESARA BLUE

K132069 is an FDA 510(k) clearance for DESARA MESH, manufactured by Caldera Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K132069 · Caldera Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
82d
Days
Class 2
Risk

K132069 is an FDA 510(k) clearance for the DESARA MESH, DESARA BLUE. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on September 23, 2013 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Caldera Medical, Inc. devices

FDA 510(k) Submission Details - K132069

510(k) Number K132069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2013
Decision Date September 23, 2013
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 131d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTN Device Classification - Class 2, Special Controls

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence 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 - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 52
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K132069.
DESARA BLUE OV, DESARA BLUE SS
K140843 · Caldera Medical · Jul 2014
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
K131229 · American Medical Systems · Dec 2013
RETROARC RETROPUBIC SLING SYSTEM
K132655 · American Medical Systems, Inc. · Nov 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · Ethicon, Inc. · Aug 2013
DESARA SL
K121928 · Caldera Medical, Inc. · Feb 2013
BLUE SUI SLING
K121754 · Boston Scientific Corp · Oct 2012