# K983299: Allegiance Genesis Container System

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Aug 4, 2000 after 683 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
Longest line of descent: 1 generation back to K844652 (1984). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844652: C.a.S.E. Container, General Medical Co. (1984) Summary page 1.
- (no number) Dental, Medical Instrument Cases & Cassettes by Sterilization Cassette Systems, Inc.: named in the summary without a submission number
- (no number) Aesculap Sterilization Container: named in the summary without a submission number

## Most influential descendants
- K112535: Genesis Reusable Rigid Container System (2012), 7 descendants of its own
- K140850: Genesis Reusable Rigid Container System (2014), 3 descendants of its own
- K142529: Genesis Reusable Rigid Container System (2015), 2 descendants of its own
- K130720: Synthes Reusable Sterilization Container System (2014), 1 descendant of its own
- K181933: DePuy Synthes Sterilization Container System (2019), 0 descendants of its own

## Indications for use
A sterilization container system, is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in prevacuum steam and ethylene oxide sterilization processes.

Source page: https://510kreport.com/device/K983299
Methodology: https://510kreport.com/methodology