Cleared Traditional

K820521 - STERILIZATION WRAP

K820521 is an FDA 510(k) clearance for STERILIZATION WRAP, manufactured by General Medical Co.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K820521 · General Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1982
Decision
20d
Days
Class 2
Risk

K820521 is an FDA 510(k) clearance for the STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by General Medical Co. (Mchenry, US). The FDA issued a Cleared decision on March 18, 1982 after a review of 20 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 General Medical Co. devices

FDA 510(k) Submission Details - K820521

510(k) Number K820521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1982
Decision Date March 18, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
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 235
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K820521.
PRO-GUARD
K830739 · Surgicot, Inc. · Mar 1983
EAGLE STERISET
K823902 · American Sterilizer Co. · Jan 1983
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982
SURGIPEEL SELF-SEAL PACKAGING SYSTEM
K820302 · Surgicot, Inc. · Feb 1982
BOUNDARY STERILIZATION WRAP
K811819 · The Buckeye Cellulose Corp. · Aug 1981
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981