# K960738: Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Custom Mfg., Inc.
- Decided: May 6, 1997 after 438 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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
No predicates in its family tree.
26 later devices descend from it; 2 cite 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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

## Recalls of this device
- Jun 8, 2011 · Not classified · Z-2612-2011: During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instrumen

Source page: https://510kreport.com/device/K960738
Methodology: https://510kreport.com/methodology