# K850289: Monarch Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Monarch Products, Inc.
- Decided: Aug 15, 1985 after 203 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041623: Reusable Sterilcontainer Filter Model #JK090 (2004), 10 descendants of its own
- K073168: Aesculap Primeline Container LTD. (2008), 9 descendants of its own
- K112671: Sterilcontainer System (2012), 7 descendants of its own
- K192056: JJ Series Container System (2020), 5 descendants of its own
- K214041: Aesculap AICON Container (2022), 4 descendants of its own

Source page: https://510kreport.com/device/K850289
Methodology: https://510kreport.com/methodology