# K101653: Miltex Thompson Cassettes; Miltex Surgical Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Miltex, Inc.
- Decided: Aug 2, 2010 after 52 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K141854: Instrument Cassette (EFCCL1-F) (2015), 0 descendants of its own

## Indications for use
Miltex Sterilization Cassettes (Miltex®, Thompson™) are general dental/surgical instrument cassettes indicated to hold instruments and accessories in place during storage and the sterilization cycle. Suitable for Gravity Steam and Pre-Vacuum Steam, the cassettes are intended to be used in conjunction with sterilization wrap in order to maintain sterility.

Source page: https://510kreport.com/device/K101653
Methodology: https://510kreport.com/methodology