Cleared Traditional

K131692 - BLOSSOM SALINE DELIVERY ASSIST DEVICE

K131692 · Marz Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
395d
Days
-
Risk

K131692 is an FDA 510(k) clearance for the BLOSSOM SALINE DELIVERY ASSIST DEVICE. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Marz Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 10, 2014 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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.

View all Marz Medical, Inc. devices

FDA 510(k) Submission Details - K131692

510(k) Number K131692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2013
Decision Date July 10, 2014
Days to Decision 395 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
280d slower than avg
Panel avg: 115d · This submission: 395d
Pathway characteristics
Predicate-based equivalence.

LCJ Device Classification - Class 0,

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 25
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K131692.
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MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813 · Mentor Corp. · Apr 2013
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp. · Dec 2001
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996