# K212505: DUMI ManipulatOR

- Pathway: 510(k) (Traditional)
- Applicant: The O R Company Pty, Ltd.
- Decided: Jan 10, 2022 after 154 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092980 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092980: Panpac Uterine Manipulator Injector, Model Umi 4.5, Panpac Medical Corporation (2010) Summary page 4.

## Indications for use
The use of the DUMI ManipulatOR is indicated in diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures where manipulation of the uterus is required.

Source page: https://510kreport.com/device/K212505
Methodology: https://510kreport.com/methodology