Cleared Traditional

K811242 - DISPOSABLE STERILIZATION WRAP

K811242 is the FDA 510(k) clearance for DISPOSABLE STERILIZATION WRAP by Amsco Co.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811242 · Amsco Co. · General Hospital
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May 1981
Decision
17d
Days
Class 2
Risk

K811242 is an FDA 510(k) clearance for the DISPOSABLE STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Amsco Co. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 17 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 Amsco Co. devices

Submission Details

510(k) Number K811242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date May 21, 1981
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 119
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K811242.
EAGLE STERISET
K823902 · American Sterilizer Co. · Jan 1983
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
ALOFT STERILIZATION WRAP
K803306 · American Hospital Supply Corp. · Feb 1981
GUARDIAN STERILIZATION WRAP
K803294 · Kimberly-Clark Corp. · Feb 1981
GUARDIAN PEEL POUCHES
K803293 · Kimberly-Clark Corp. · Jan 1981