# K010471: Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, Inc.
- Decided: Jun 6, 2001 after 106 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter (2004), 40 descendants of its own
- K160335: Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (2016), 25 descendants of its own
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled (2018), 21 descendants of its own
- K192037: Advisor VL Circular Mapping Catheter, Sensor Enabled (2019), 18 descendants of its own
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (2020), 17 descendants of its own

Source page: https://510kreport.com/device/K010471
Methodology: https://510kreport.com/methodology