Cleared Traditional

K971483 - SECURE-WRAP (TM) STERILIZATION WRAP

K971483 is an FDA 510(k) clearance for SECURE-WRAP (TM) STERILIZATION WRAP, manufactured by American Threshold Industries, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K971483 · American Threshold Industries, Inc. · General Hospital
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Jun 1997
Decision
62d
Days
Class 2
Risk

K971483 is an FDA 510(k) clearance for the SECURE-WRAP (TM) STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by American Threshold Industries, Inc. (Enka, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 62 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 American Threshold Industries, Inc. devices

FDA 510(k) Submission Details - K971483

510(k) Number K971483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1997
Decision Date June 24, 1997
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 233
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K971483.
DENTAL STERLIZATION TRAY/CASSETTE
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CARR RIGID CONTAINER SYSTEM
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CYGNUS INSTRUMENT PROTECTORS
K964256 · Madison Polymeric Engineering · May 1997
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
K962605 · Surgicot, Inc. · Mar 1997
BIOPSY TRAY
K970152 · Medcare Medical Group, Inc. · Mar 1997