# K120330: Penumbra Coil System/Penumbra Coil 400

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Apr 2, 2012 after 60 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: 9 generations back to K951256 (1995). 35 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103305: Penumbra Embolization Coil System, Penumbra, Inc. (2011) Summary page 1.

## Most influential descendants
- K143218: Penumbra Smart Coil (2015), 4 descendants of its own
- K151572: Penumbra Smart Coil (2015), 3 descendants of its own
- K160832: Penumbra Smart Coil (2016), 2 descendants of its own
- K192955: Penumbra LP Coil System (2019), 1 descendant of its own
- K173614: Penumbra Coil 400, Ruby Coil System, POD System (2018), 1 descendant of its own

## Indications for use
The Penumbra Coil System is indicated for the embolization of: - Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - Arterial and venous embolizations in the peripheral vasculature

Source page: https://510kreport.com/device/K120330
Methodology: https://510kreport.com/methodology