# K052075: Procedur-10

- Pathway: 510(k) (Special)
- Applicant: Avanca Medical Devices, Inc.
- Decided: Nov 9, 2005 after 100 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K980987 (1998). 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)
- K042486: Procedur 10 Syringe Device, Avanca Medical Devices, Inc. (2005) Summary page 1.

## Indications for use
The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K052075
Methodology: https://510kreport.com/methodology