Cleared Traditional

K993871 - BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP

K993871 is an FDA 510(k) clearance for BIOSHIELD HEAVY DUTY AND SUPER DUTY EXP..., manufactured by Allegiance Healthcare Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K993871 · Allegiance Healthcare Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
158d
Days
Class 2
Risk

K993871 is an FDA 510(k) clearance for the BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on April 21, 2000 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K993871

510(k) Number K993871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date April 21, 2000
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
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 240
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K993871.
MEDLINE STERISET STERILIZATION CONTAINER
K010825 · Medline · May 2001
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc. · Jan 2001
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · Allegiance Healthcare Corp. · Aug 2000
STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL
K991023 · Case Medical, Inc. · Jan 2000
PARAPOST SYSTEM STERILIZABLE ORGANIZER
K993835 · Coltene/Whaledent, Inc. · Dec 1999
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
K993255 · Coltene/Whaledent, Inc. · Dec 1999