Cleared Traditional

K960206 - CPR DRESSING CHANGE TRAY

K960206 is an FDA 510(k) clearance for CPR DRESSING CHANGE TRAY, manufactured by Custom Pack Reliability. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K960206 · Custom Pack Reliability · General Hospital
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Apr 1996
Decision
87d
Days
Class 2
Risk

K960206 is an FDA 510(k) clearance for the CPR DRESSING CHANGE TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on April 12, 1996 after a review of 87 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 Custom Pack Reliability devices

FDA 510(k) Submission Details - K960206

510(k) Number K960206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date April 12, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
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 185
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K960206.
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
SECURE-WRAP (TM) STERILIZATION WRAP
K971483 · American Threshold Industries, Inc. · Jun 1997
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
K962605 · Surgicot, Inc. · Mar 1997
CPR ORTHO HAND PACK
K960210 · Custom Pack Reliability · Apr 1996
CPR TOTAL KNEE PACK
K960211 · Custom Pack Reliability · Apr 1996
CPR TOTAL HIP PACK
K960213 · Custom Pack Reliability · Apr 1996