# K221854: Reprocesses Umbilical Cable

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Aug 6, 2022 after 40 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 K102588 (2011). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193263: Reprocessed Achieve Catheter Connecting Cable, Innovative Health, LLC (2020) Summary page 5.

## Indications for use
The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

Source page: https://510kreport.com/device/K221854
Methodology: https://510kreport.com/methodology