# K030853: Steritite Perforated Base Rigid Reusable Sterilization Container System with SCF02-Polypropylene Non-Woven Disposable FI

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Mar 21, 2003 after 3 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991023 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991023: Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 - Polypropylene Non-Woven Disposabl, Case Medical, Inc. (2000) Summary page 2.

## Most influential descendants
- K161415: SteriTite Containers System & MediTray Products (2017), 0 descendants of its own

## Recalls of this device
- Oct 3, 2013 · Class III · Z-0434-2014: Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle 

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

Source page: https://510kreport.com/device/K030853
Methodology: https://510kreport.com/methodology