510(k) · Cleared
ClearedReprocessed Electrophysiology Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Sep 26, 2011 as substantially equivalent to K081329 (Ascent Healthcare Solutions, 2008) and 7 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 26, 2011
- Review
- 53 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K961924 (1997). 8 ancestors in all, the oldest K946333 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
- 2 generations backK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
- 1 generation backK060757 Inquiry Optima Plus Steerable Electrophysiology CatheterIrvine Biomedical, Inc. · 2006
- This deviceK112232 Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961924 | Ibi-1100 Steerable Electrophysiology Catheter System | Irvine Biomedical, Inc. | 1997 | 2 |
| −2 | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable… | Irvine Biomedical, Inc. | 2004 | — |
| −1 | K060757 | Inquiry Optima Plus Steerable Electrophysiology Catheter | Irvine Biomedical, Inc. | 2006 | — |
| 0 (this device) | K112232 | Reprocessed Electrophysiology Catheters | Stryker Sustainability Solutions | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NLH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NLH device
- #1 K252405 Medline ReNewal Reprocessed Boston Scientific…score 10.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081329 | Reprocessed Electrophysiology CathetersSummary page 1…Name: Electrode recording catheter or electrode recording probe Predicate Device 510(k) Title Manufacturer K081329 Reprocessed Electrophysiology Ascent Healthcare Catheters… | 2008 |
| * | K060757 | Inquiry Optima Plus Steerable Electrophysiology CatheterSummary page 1…turer K081329 Reprocessed Electrophysiology Ascent Healthcare Catheters Solutions K060757 Inquiry Optima Plus Steerable Irvine Biomedical Electrophysiology Catheter K… | 2006 |
| * | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterSummary page 1…Solutions K060757 Inquiry Optima Plus Steerable Irvine Biomedical Electrophysiology Catheter K042775 lnquiryTm AFoCUSTM, lnquiryTM Irvine Biomedical AFocuslITM, or lnquiryTM Opt… | 2004 |
| * | K010471 | Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569Summary page 1…oCUSTM, lnquiryTM Irvine Biomedical AFocuslITM, or lnquiryTM OptimaTM Steerable Electrophysiology Catheter K(010471 InquiryTm AFOCU5TM Steerable Irvine Biomedical Electrophysiology Catheter K(… | 2001 |
| * | K990958 | Orthogonal EP CathetersSummary page 1…able Electrophysiology Catheter K(010471 InquiryTm AFOCU5TM Steerable Irvine Biomedical Electrophysiology Catheter K(990958 Orthogonal TM Steerable Irvine Biomedical Electrophysiology Catheter K(… | 1999 |
| * | K982232 | Modification of the Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 1…Electrophysiology Catheter K(990958 Orthogonal TM Steerable Irvine Biomedical Electrophysiology Catheter K(982232 18-1 100 Bi-directional Steerable Irvine Biomedical Electrophysiology Catheter K9… | 1998 |
| * | K961924 | Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 1…Electrophysiology Catheter K(982232 18-1 100 Bi-directional Steerable Irvine Biomedical Electrophysiology Catheter K961924 IBI-1 100 Steerable Electrophysiology Irvine Biomedical Catheter K946333… | 1997 |
| * | K946333 | Ibi-1000(TM) Electrophysiology CathterSummary page 1…l Electrophysiology Catheter K961924 IBI-1 100 Steerable Electrophysiology Irvine Biomedical Catheter K946333 IBI1-1000'r m Electrophysiology Irvine Biomedical Catheter Device description:… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NLH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NLH
165in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLH
28so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NLH
66in 2025
MAUDE reports naming product code NLH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 120 | 0 | 8 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 6 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 11 | 133 | 3 | 25 |
| 2017 | 4 | 138 | 0 | 11 |
| 2018 | 4 | 122 | 4 | 21 |
| 2019 | 4 | 195 | 0 | 38 |
| 2020 | 2 | — | 0 | 28 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 1 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 30 |
| 2024 | 6 | 165 | 0 | 47 |
| 2025 | 2 | — | 0 | 66 |
| 2026 | 0 | — | 28 (1) | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112232: Reprocessed Electrophysiology Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112232
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026