# K180791: Straumann BLX Surgical Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jun 21, 2018 after 86 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: 8 generations back to K844002 (1984). 14 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163600: Kit Boxes and Kit Plates, Nobel Biocare AB (2018) Summary page 4.

## Most influential descendants
- K212281: Surgical Trays (2022), 5 descendants of its own
- K220791: Surgical and Prosthetic Trays (2022), 2 descendants of its own
- K191522: Straumann Modular Cassette (2019), 2 descendants of its own
- K223672: Instrument Case P1340904 (2023), 1 descendant of its own
- K203753: Straumann Surgical Cassettes (2021), 1 descendant of its own

## Indications for use
The Straumann BLX Cassette is used in healthcare facilities to organize, enclose, cleaning, sterilize, transport, and store medical devices between surgical uses. The BLX Cassette is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated sterilization wrap. The BLX Cassette has been validated for a maximum load of 300 grams, including cassette and instruments. Sterilization parameters: Pre-vacuum steam: 132°C (270° F) for 4 minutes with 20 minutes drying time.

Source page: https://510kreport.com/device/K180791
Methodology: https://510kreport.com/methodology