# K253791: PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Mitek, Inc.
- Decided: Feb 26, 2026 after 90 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: 10 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)
- K241927: Synthes Graphic Case & Tray System, Synthes GmbH (2025) Summary page 6.

## Indications for use
The PUREVUE™ Quick Connect Cannula System Tray and PUREVUE™ Quick Connect Cannula System Lid are used to store, organize, and transport PUREVUE™ Quick Connect Cannula System instruments during sterilization and surgical procedures. The tray and lid are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier wrap. The tray and lid were validated for a maximum load of 22.1 lb (tray + contents + lid + wrap).

Source page: https://510kreport.com/device/K253791
Methodology: https://510kreport.com/methodology