# K241378: S.I.N. Instrument Kits

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
- Decided: Jul 12, 2024 after 58 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: 11 generations back to K844002 (1984). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201688: S.I.N. Instrument Kits, S.I.N. - Sistema DE Implante Nacional S.A. (2020) Summary page 5.

## Indications for use
S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement – Exposure at 121 °C for 30 minutes and 30 minutes dry time. S.I.N. Instrument Kits are intended for sterilization of non-porous loads. S.I.N. Instrument Kits are recommended not to be stacked during sterilization. The combined weight of the Epikut PTG Surgical Kit and associated instruments is 632 grams. The weight of the empty Epikut PTG Surgical Kit is 353 grams.

Source page: https://510kreport.com/device/K241378
Methodology: https://510kreport.com/methodology