# K991023: Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 - Polypropylene Non-Woven Disposabl

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Jan 27, 2000 after 304 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.
21 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spunguard wrap/SteriTite® Container System: named in the summary without a submission number

## Most influential descendants
- K012931: Genesis Sterrad Compatible Reusable Sterilization Container System (2002), 18 descendants of its own
- K023614: Steritite Rigid Reusable Sterilization Container System (2003), 9 descendants of its own
- K112535: Genesis Reusable Rigid Container System (2012), 7 descendants of its own
- K050570: Miltex Rigid Sterilization Container System (2005), 7 descendants of its own
- K091720: Sklarlite Rigid Sterilization Container System (2010), 6 descendants of its own

## Indications for use
The perforated base containers are part of the SteriTite® Reusable Rigid Sterilization Container system. The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100 Sterilization for a hospital or other health care facilities.

Source page: https://510kreport.com/device/K991023
Methodology: https://510kreport.com/methodology