Cleared Traditional

MONARCH STERILIZATION CONTAINER SYSTEM (K850289) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K850289 · Monarch Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
203d
Days
Class 2
Risk

K850289 is an FDA 510(k) clearance for the MONARCH STERILIZATION CONTAINER SYSTEM. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Monarch Products, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 15, 1985 after a review of 203 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 Monarch Products, Inc. devices

Submission Details

510(k) Number K850289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1985
Decision Date August 15, 1985
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
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 88
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K850289.
G.E. STERILE PUNCTURE TRAY
K960202 · GE Medical Systems · Feb 1996
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
STERILIZER WRAP
K770514 · C.R. Bard, Inc. · Apr 1977