Cleared Traditional

K961227 - JJ SKINNER CAREKITS WOUND CARE MANAGEME...

K961227 is an FDA 510(k) clearance for JJ SKINNER CAREKITS WOUND CARE MANAGEME..., manufactured by J.J. Skinner, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K961227 · J.J. Skinner, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
74d
Days
Class 2
Risk

K961227 is an FDA 510(k) clearance for the JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by J.J. Skinner, Inc. (Louisville, US). The FDA issued a Cleared decision on June 10, 1996 after a review of 74 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 J.J. Skinner, Inc. devices

FDA 510(k) Submission Details - K961227

510(k) Number K961227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1996
Decision Date June 10, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 129d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 125
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K961227.
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · Allegiance Healthcare Corp. · Apr 2000
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · Allegiance Healthcare Corp. · Aug 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · GE Medical Systems · Feb 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · GE Medical Systems · Feb 1996
G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY
K960201 · GE Medical Systems · Feb 1996