# K092827: Dimela Obsterical Forceps, Model 72.1 XX XX

- Pathway: 510(k) (Traditional)
- Applicant: Dimeda Instrumente GmbH
- Decided: Jan 8, 2010 after 116 days
- Product code: HDA (Forceps, Obstetrical)
- Device class: 2
- Regulation: 21 CFR 884.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951529 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013747: Tekno-Medical Obstetrical Forceps, Tekno Medical Optik-Chirurgie GmbH & Co. (2002) Summary page 1.
- K951529: V. Mueller Obstetrical (OB) Forceps, Baxter Healthcare Corp (1995) Summary page 2.

## Indications for use
The Dimeda Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate vaginal delivery, provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina. Use of the forceps is indicated for: o prolonged second stage o suspicion of immediate or potential fetal compromise o shortening of the second stage for maternal benefit

Source page: https://510kreport.com/device/K092827
Methodology: https://510kreport.com/methodology