# K122756: Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Oct 2, 2012 after 25 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 8 cite it directly.
5 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K081758: Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015, Depuy Spine, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K160449: Penumbra System, Penumbra Pump MAX (2016), 31 descendants of its own
- K161640: Penumbra System ACE 68 Reperfusion Catheter (2016), 17 descendants of its own
- K162901: Penumbra 3D Revascularization Device (2017), 16 descendants of its own
- K173761: Penumbra System Reperfusion Catheter JET 7 (2018), 10 descendants of its own
- K173841: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm (2018), 6 descendants of its own

## Indications for use
The Penumbra Pump MIAXTM is intended for general suction use in hospitals or clinics.

Source page: https://510kreport.com/device/K122756
Methodology: https://510kreport.com/methodology