# K100517: Instrumed Forceps Obsterical, Model# 46-5XXX, OB-XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Instrumed International, Inc.
- Decided: Apr 29, 2010 after 65 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 1.

## Indications for use
INSTRUIMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: * prolonged second stage * suspicion of immediate or potential fetal compromise * shortening of the second stage for maternal benefit

Source page: https://510kreport.com/device/K100517
Methodology: https://510kreport.com/methodology