Cleared Traditional

K134037 - PREMVIA

K134037 · Biotime, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
219d
Days
-
Risk

K134037 is an FDA 510(k) clearance for the PREMVIA. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Biotime, Inc. (Austin, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 219 days - an extended review cycle.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K134037

510(k) Number K134037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2013
Decision Date August 07, 2014
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 184
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K134037.
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ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
K140367 · Harbor Medtech, Inc. · Sep 2014
BIO-CONNEKT WOUND MATRIX
K140456 · MLM Biologics, Inc. · Jul 2014
MIROMATRIX WOUND MATRIX
K140510 · Miromatrix Medical, Inc. · Jun 2014
COLLACARE DENTAL
K133290 · Innocoll Pharmaceuticals · May 2014
K134037 · PREMVIA
Download PDF FDA Summary Biotime, Inc.