# K254221: Optima Coil System (OptiOne Coil System)

- Pathway: 510(k) (Special)
- Applicant: Balt USA, LLC
- Decided: Jan 27, 2026 after 29 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K951256 (1995). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252700: Optima Coil System (Optima Packing Coil System), Balt USA, LLC (2025) Summary page 5.

## Indications for use
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K254221
Methodology: https://510kreport.com/methodology