Cleared Traditional

K944854 - STERISURE STERILIZATION WRAP

K944854 is an FDA 510(k) clearance for STERISURE STERILIZATION WRAP, manufactured by Fiberweb North America, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K944854 · Fiberweb North America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
80d
Days
Class 2
Risk

K944854 is an FDA 510(k) clearance for the STERISURE STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Fiberweb North America, Inc. (Simpsonville, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 80 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 Fiberweb North America, Inc. devices

FDA 510(k) Submission Details - K944854

510(k) Number K944854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1994
Decision Date December 19, 1994
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 239
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K944854.
STERIMED STERIZATION WRAPPER (NON-STERILE)
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