Cleared Traditional

K152538 - JRP Wound Spreader

K152538 is an FDA 510(k) clearance for JRP Wound Spreader, manufactured by J.R. Parker, LLC. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K152538 · J.R. Parker, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
222d
Days
Class 1
Risk

K152538 is an FDA 510(k) clearance for the JRP Wound Spreader. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by J.R. Parker, LLC (West Chester, US). The FDA issued a Cleared decision on April 13, 2016 after a review of 222 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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. 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 - K152538

510(k) Number K152538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2015
Decision Date April 13, 2016
Days to Decision 222 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
107d slower than avg
Panel avg: 115d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAD Retractor

All 71
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K152538.
OTELO LL
K151104 · Spineart · Jan 2016
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc. · Oct 2013
DASH
K071775 · Ezsurgical · Aug 2007
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
K050256 · Apple Medical Corp. · Apr 2005
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
MRI FASTSYSTEM RETRACTOR SYSTEM
K001339 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · May 2000
K152538 · JRP Wound Spreader
Download PDF FDA Summary J.R. Parker, LLC