# K946333: Ibi-1000(TM) Electrophysiology Cathter

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Biomedical, Inc.
- Decided: Jul 18, 1995 after 201 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.
5 later devices descend from it; 5 cite it directly.
0 of 6 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
- K081329: Reprocessed Electrophysiology Catheters (2008), 1 descendant of its own
- K210313: EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (2022), 0 descendants of its own
- K112232: Reprocessed Electrophysiology Catheters (2011), 0 descendants of its own
- K101789: Reprocessed Electrophysiology Diagnostic Catheters (2010), 0 descendants of its own
- K021421: Padtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K946333
Methodology: https://510kreport.com/methodology