Cleared Traditional

K110954 - ARJORAD STERILE WRAP

K110954 is an FDA 510(k) clearance for ARJORAD STERILE WRAP, manufactured by Arjo Wiggins Medical, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K110954 · Arjo Wiggins Medical, Inc. · General Hospital
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Aug 2012
Decision
507d
Days
Class 2
Risk

K110954 is an FDA 510(k) clearance for the ARJORAD STERILE WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Arjo Wiggins Medical, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on August 24, 2012 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Arjo Wiggins Medical, Inc. devices

FDA 510(k) Submission Details - K110954

510(k) Number K110954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2011
Decision Date August 24, 2012
Days to Decision 507 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
378d slower than avg
Panel avg: 129d · This submission: 507d
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 226
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