# K091720: Sklarlite Rigid Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Sklar Corp.
- Decided: Apr 9, 2010 after 302 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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: 4 generations back to K991023 (2000). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050570: Miltex Rigid Sterilization Container System, Miltex, Inc. (2005) Summary page 1.

## Most influential descendants
- K102146: Bahadir Sterilization Trays (2010), 3 descendants of its own
- K112090: Bahadir Sterilization Trays (2012), 2 descendants of its own
- K131407: Bahadir Sterilization Trays (2014), 1 descendant of its own
- K123234: Ermis Sterilization Container System (2013), 1 descendant of its own
- K233578: Bahadir Sterilization Containers (2024), 0 descendants of its own

## Indications for use
The SklarLiteTm Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270'F for 4 minutes with 30 minutes (minimum) dry time. The containers have been validated for sterilization of up to two instruments with lumens no smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length for the Full-Size (580mm x 280mm) and Mid-Size (465mm x 280mm) containers, and no smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length for the Half-Size (285mm x 280mm) container. Containers have been validated for a combined maximum load of 25lbs. with up to two internal stacked baskets and up to two silicon mats (one mat per basket) for the Full-Size, Mid-Size and Half-Size containers. Both solid and perforated bottom containers, maximum depth 150mm/each, can be stacked a maximum of 3 containers high during sterilization. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the contents for up to six (6)months.

Source page: https://510kreport.com/device/K091720
Methodology: https://510kreport.com/methodology