510(k) · Cleared
ClearedReprocessed Dynamic Tip and XT 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 15, 2021 as substantially equivalent to K161464 (Innovative Health, LLC, 2016) and 1 other predicate after a 141-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Sep 15, 2021
- Review
- 141 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891908 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK891908 Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc. · 1989
- 1 generation backK161464 Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology…Innovative Health, LLC · 2016
- This deviceK211276 Reprocessed Dynamic Tip and XT Steerable Diagnostic…Innovative Health, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891908 | Bard (R) Tip Deflecting Electrode Catheter | C.R. Bard, Inc. | 1989 | — |
| −1 | K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2016 | — |
| 0 (this device) | K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2021 | — |
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 |
|---|---|---|---|
| * | K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersSummary page 5…Product Code: NLH Predicate Device: 510(k) Number Device Manufacturer K161464 Reprocessed Dynamic Tip Steerable Innovative Health, LLC. Diagnostic El… | 2016 |
| * | K891908 | Bard (R) Tip Deflecting Electrode CatheterSummary page 5…161464 Reprocessed Dynamic Tip Steerable Innovative Health, LLC. Diagnostic Electrophysiology Catheter K891908 Bard Tip Deflecting Electrode Catheter C.R. Bard, Inc. Device Description: The Reprocessed… | 1989 |
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 32 years and passes through 2 companies; a new generation was cleared every 27.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 and Dynamic XT Steerable Diagnostic EP 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/K211276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211276: Reprocessed Dynamic Tip and XT Steerable Diagnostic 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/K211276
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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