# K152699: Apollo System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Mar 17, 2016 after 178 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- 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 K853143 (1985). 11 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132931: Apollo System, Penumbra, Inc. (2014) Summary page 4.
- K990572: Sonotome, Sonokinetics, Inc. (1999) Summary page 4.

## Most influential descendants
- K171332: Artemis Neuro Evacuation Device (2017), 2 descendants of its own
- K201308: Axonpen, Axonmonitor, Axonbox, Tablet (2020), 1 descendant of its own
- K230125: Neuroblade System (2023), 0 descendants of its own
- K181731: MR Compatible Aspiration Kit (2018), 0 descendants of its own

## Indications for use
The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

Source page: https://510kreport.com/device/K152699
Methodology: https://510kreport.com/methodology