# K974638: Steritite Sealed Containers Model SCO4Q

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Dec 18, 1997 after 69 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.
26 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products (2003), 25 descendants of its own
- K053389: Aesculap Sterilcontainer System (2006), 12 descendants of its own
- K073168: Aesculap Primeline Container LTD. (2008), 9 descendants of its own
- K112671: Sterilcontainer System (2012), 7 descendants of its own
- K072563: Miltex Rigid Container Systems (2008), 7 descendants of its own

## Indications for use
The SteriTite & product line is a Reusable Rigid Sterilization Container system intended to be used for the sterilization of surgical instruments for a hospital or other health care institution.

Source page: https://510kreport.com/device/K974638
Methodology: https://510kreport.com/methodology