Cleared Traditional

K885019 - BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.

K885019 is an FDA 510(k) clearance for BEMIS STERILE-CASE FOR USE W/ETHYLENE O..., manufactured by Bemis Health Care. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K885019 · Bemis Health Care · General Hospital
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Jan 1989
Decision
57d
Days
Class 2
Risk

K885019 is an FDA 510(k) clearance for the BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Bemis Health Care (Sheboygan Falls, US). The FDA issued a Cleared decision on January 25, 1989 after a review of 57 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.

FDA 510(k) Submission Details - K885019

510(k) Number K885019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1988
Decision Date January 25, 1989
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 274
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K885019.
MONARCH STERILIZATION CONTAINER SYST, MODIFICATION
K911760 · Monarch Products, Inc. · Jun 1991
PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH
K894437 · Clive Craig Co. · Jan 1990
STERILIZATION TRAY LINER
K893764 · Ahlstrom Dexter · Aug 1989
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · Kimberly-Clark Corp. · Aug 1988
CENTRAL SUPPLY ROOM WRAP
K873175 · Ulti-Med Intl., Inc. · Sep 1987
STERILIZATION WRAPS #620,624,648,640,636,630,612
K863981 · Graham Medical Products · Nov 1986
K885019 · BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
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