# K112232: Reprocessed Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Sep 26, 2011 after 53 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- 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: 3 generations back to K961924 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081329: Reprocessed Electrophysiology Catheters, Ascent Healthcare Solutions (2008) Summary page 1.
- K060757: Inquiry Optima Plus Steerable Electrophysiology Catheter, Irvine Biomedical, Inc. (2006) Summary page 1.
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter, Irvine Biomedical, Inc. (2004) Summary page 1.
- K010471: Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569, Irvine Biomedical, Inc. (2001) Summary page 1.
- K990958: Orthogonal EP Catheters, Irvine Biomedical, Inc. (1999) Summary page 1.
- K982232: Modification of the Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1998) Summary page 1.
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997) Summary page 1.
- K946333: Ibi-1000(TM) Electrophysiology Cathter, Irvine Biomedical, Inc. (1995) Summary page 1.

## Indications for use
Reprocessed Diagnostic Electrophysiology (EP) Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The reprocessed IBI AFocus Steerable and the Inquiry Optima catheters are to be used to map the atrial regions of the heart. The reprocessed Inquiry fixed curve and steerable catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

Source page: https://510kreport.com/device/K112232
Methodology: https://510kreport.com/methodology