# K191522: Straumann Modular Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Dec 3, 2019 after 176 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: 9 generations back to K844002 (1984). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180791: Straumann BLX Surgical Cassette, Institut Straumann AG (2018) Summary page 5.

## Most influential descendants
- K203753: Straumann Surgical Cassettes (2021), 1 descendant of its own
- K233264: Anthogyr INTEGRAL Guided Surgery Cassettes (2023), 0 descendants of its own

## Indications for use
Straumann® Modular Cassette is used in healthcare facilities to organize, enclose, sterilize, transport and store Straumann instruments between surgical uses. Straumann® Modular Cassette is not intended to maintain sterility on its own, but is intended to be used in conjunction with a legally marketed, validated sterilization double pouch to maintain the sterility of the enclosed devices. The Straumann® Modular Cassette has been validated for the following maximum loads: • Module A 400g • BCC Maximum permissible stack BCC 611g The A module is intended to be sterilized individually, without stacking with other modules. The B and C module are intended to be sterilized individually, or by stacking the B module on top of C module bases. The maximum permissible stack for sterilization is one B module on top of two C module bases. The B module lid and C module lid could be used to enclose an ultrasonic mat (Art. No. 041.774) for ultrasonic bath cleaning used instruments. Only use the following sterilization parameters: • Pre-vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time

Source page: https://510kreport.com/device/K191522
Methodology: https://510kreport.com/methodology