# K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, Inc.
- Decided: Nov 4, 2004 after 29 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
Longest line of descent: 1 generation back to K961924 (1997). 2 ancestors in all.
40 later devices descend from it; 11 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010471: Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569, Irvine Biomedical, Inc. (2001) Summary page 1.
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K212061: EnSite X EP System (2021), 13 descendants of its own

## Indications for use
The Steerable Electrophysiology Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheter is indicated for mapping the atrial regions of the heart.

Source page: https://510kreport.com/device/K042775
Methodology: https://510kreport.com/methodology