510(k) · Cleared
ClearedReprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
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 Sep 30, 2016 as substantially equivalent to K891908 (C.R. Bard, Inc., 1989) after a 127-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Sep 30, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891908 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK891908 Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc. · 1989
- This deviceK161464 Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology…Innovative Health, LLC · 2016
- Descendant · cites it directly · 0 of its ownK211276 Reprocessed Dynamic Tip and XT Steerable Diagnostic…Innovative Health, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891908 | Bard (R) Tip Deflecting Electrode Catheter | C.R. Bard, Inc. | 1989 | — |
| 0 (this device) | K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2016 | — |
| +1 | K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K891908 | Bard (R) Tip Deflecting Electrode CatheterSummary page 5…Product Code: NLH Predicate Device: 510(k) Number 510(k) Title Manufacturer K891908 Bard Tip Deflecting Electrode Catheter C.R. Bard, Inc. Device Description: The Reprocess… | 1989 |
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 |
|---|---|---|---|
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | 2021 | 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?
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 Dynamic Tip Steerable Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161464: Reprocessed Dynamic Tip Steerable Diagnostic 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/K161464
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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