# K242225: Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Nov 29, 2024 after 123 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 2 (2 Class I)
- 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.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982232: Modification of the Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1998) Summary page 6.
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997) Summary page 6.

## Recalls of this device
- Dec 22, 2025 · Class I · Z-1320-2026: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous react
- Jul 31, 2025 · Class I · Z-2612-2025: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is

## Indications for use
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters can be used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

Source page: https://510kreport.com/device/K242225
Methodology: https://510kreport.com/methodology