510(k) · Cleared
ClearedReprocessed Electrophysiology Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Jul 9, 2008 as substantially equivalent to K042775 (Irvine Biomedical, Inc., 2004) and 5 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jul 9, 2008
- Review
- 58 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K961924 (1997). 6 ancestors in all, the oldest K946333 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
- 1 generation backK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
- This deviceK081329 Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008
- Descendant · cites it directly · 0 of its ownK112232 Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011
Most influential descendants
Showing 1 of 1 · See all- K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961924 | Ibi-1100 Steerable Electrophysiology Catheter System | Irvine Biomedical, Inc. | 1997 | 2 |
| −1 | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable… | Irvine Biomedical, Inc. | 2004 | — |
| 0 (this device) | K081329 | Reprocessed Electrophysiology Catheters | Ascent Healthcare Solutions | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (6)
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 |
|---|---|---|---|
| * | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterSummary page 1…Name: Electrode recording catheter or electrode recording probe Predicate Device 510(k) Title Manufacturer K042775 Inquiry TM AFocus TM , Inquiry TM Irvine Biomedical AFocuslITM, or InquiryTM Op… | 2004 |
| * | K010471 | Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569Summary page 1…le Electrophysiology Catheter M AFocus TM Steerable Inquiry T Irvine Biomedical K010471 Electrophysiology Catheter K990958 Orthogonal TM Steerable Irvine Bio… | 2001 |
| * | K990958 | Orthogonal EP CathetersSummary page 1…M AFocus TM Steerable Inquiry T Irvine Biomedical K010471 Electrophysiology Catheter K990958 Orthogonal TM Steerable Irvine Biomedical Electrophysiology Catheter… | 1999 |
| * | K982232 | Modification of the Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 1…Electrophysiology Catheter K990958 Orthogonal TM Steerable Irvine Biomedical Electrophysiology Catheter K982232 IBI-1100 Bi-directional Steerable Irvine Biomedical Electrophysiology Catheter… | 1998 |
| * | K961924 | Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 1…Electrophysiology Catheter K982232 IBI-1100 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…Electrophysiology Catheter K961924 IBI-1 100 Steerable Electrophysiology Irvine Biomedical Catheter K946333 IBI-1000 TM Electrophysiology Irvine Biomedical Catheter Device description… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112232 | Reprocessed Electrophysiology Catheters | 2011 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K112232 (Stryker Sustainability Solutions, 2011) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K042775.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081329 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081329: Reprocessed Electrophysiology Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081329
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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