510(k) · Cleared
ClearedReprocessed Livewire Steerable Diagnostic Electrophysiology 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 Aug 23, 2019 as substantially equivalent to K160242 (Innovative Health, LLC, 2016) and 1 other predicate after a 207-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Aug 23, 2019
- Review
- 207 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913940 (1993). 13 ancestors in all, the oldest K894500 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK913940 Response (TM) Steerable CatheterDaig Corp. · 1993
- 3 generations backK102721 Livewire Electophysiology CatheterSt Jude Medical · 2010
- 2 generations backK150631 St. Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- 1 generation backK151622 St.Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
- This deviceK190127 Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterInnovative Health, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913940 | Response (TM) Steerable Catheter | Daig Corp. | 1993 | — |
| −3 | K102721 | Livewire Electophysiology Catheter | St Jude Medical | 2010 | — |
| −2 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology… | St Jude Medical | 2015 | — |
| −1 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology… | St Jude Medical | 2015 | — |
| 0 (this device) | K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K160242 | Reprocessed Livewire Steerable Diagnostic EP CatheterSummary page 6…Product Code: NLH Predicate Device: 510(k) Number 510(k) Device Manufacturer K160242 Reprocessed Livewire Steerable Innovative Health, LLC. Diagnostic EP Ca… | 2016 |
| * | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…Summary page 6…acturer K160242 Reprocessed Livewire Steerable Innovative Health, LLC. Diagnostic EP Catheter K151622 Livewire Electrophysiology Catheter St. Jude Medical Device Description: The Reprocessed Li… | 2015 |
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 26 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 13 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. 2019, 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 Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190127: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190127
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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