# K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: May 9, 2003 after 245 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 K871202 (1987). 4 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960738: Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H), Engineered Custom Mfg., Inc. (1997) Summary page 1.
- K974638: Steritite Sealed Containers Model SCO4Q, Case Medical, Inc. (1997) Summary page 1.
- K871202: Flashpak Container System, Performance Instruments Corp. (1987) Summary page 1.
- K962545: Dental, Medical Instrument Cases & Cassette, Sterilization Cassette Systems, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K541669: FlashGuard Container System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- 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
- K192056: JJ Series Container System (2020), 5 descendants of its own

## Indications for use
The StariTite@containers with r;laslil'ite@ ualvc plate(s) are intcnded to be used in conjunction with MediTray basic tray for the flash sterilization of one iiistrurnent or instrument set. The SteriTile container system with MediTray product are intended to be used to contain niedical devices for steam sterilization. The full line of MediTmy product is intended for complex customizotion in pre-Vacuum steam sterili7atioa MediTray basic trays are intcnded to be used in the sealed container for sterilization jn steam pre-vacuum and gravity sterilization. MediTray products may be used scparntely for sterilizarion when wnpped in FDA cleared medical grade wrappers. The MediTny products include casehays with lid and base, insert boxes, casetlcs, trays, baskets, instrument ncks, si1icone mats, brackets, posts, partitions.

Source page: https://510kreport.com/device/K022978
Methodology: https://510kreport.com/methodology