510(k) · Cleared
ClearedReprocessed Inquiry Steerable Diagnostic EP Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Jun 10, 2016 as substantially equivalent to K082061 (Irvine Biomedical, Inc., 2008) and 2 other predicates after a 109-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jun 10, 2016
- Review
- 109 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K961924 (1997). 4 ancestors in all. 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 backK082061 Inquiry H-Curve TV Steerable Diagnostic CatheterIrvine Biomedical, Inc. · 2008
- This deviceK160496 Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC · 2016
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 | K082061 | Inquiry H-Curve TV Steerable Diagnostic Catheter | Irvine Biomedical, Inc. | 2008 | — |
| 0 (this device) | K160496 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K082061 | Inquiry H-Curve TV Steerable Diagnostic CatheterSummary page 5…Product Code: NLH Predicate Device: 510(k) Number 510(k) Title Manufacturer K082061 Inquiry H-Curve TV Steerable Diagnostic Irvine Biomedical, Inc. Catheter… | 2008 |
| * | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterSummary page 5…Manufacturer K082061 Inquiry H-Curve TV Steerable Diagnostic Irvine Biomedical, Inc. Catheter K042775 Inquiry AFocus, Inquiry AFocus II and Irvine Biomedical, Inc. Inquiry Optima S… | 2004 |
| * | K961924 | Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 5…ry AFocus II and Irvine Biomedical, Inc. Inquiry Optima Steerable Electrophysiology Catheter K961924 IBI-1100 Steerable Electrophysiology Irvine Biomedical, Inc. Catheter System… | 1997 |
| † | K112232 | Reprocessed Electrophysiology Catheters | 2011 |
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 19 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 4 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. 2016, 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?
The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160496: Reprocessed Inquiry Steerable Diagnostic EP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160496
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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