510(k) · Cleared
ClearedReprocessed IntellaMap Orion High Resolution Mapping Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed
Cleared on Nov 18, 2021 as substantially equivalent to K192360 (Boston Scientific Corporation, 2019) after a 170-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Nov 18, 2021
- Review
- 170 days
- Class
- Class II
- Product code
- NLG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011361 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK011361 Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector CableCatheffects, LLC · 2001
- 3 generations backK122461 Rhythmia Mapping CatheterRhythmia Medical, Inc. · 2013 · Recalled
- 2 generations backK143481 IntellaMap Orion High Resolution Mapping CatheterRhythmia Medical, Inc. · 2015
- 1 generation backK192360 IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation · 2019
- This deviceK211662 Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011361 | Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector Cable | Catheffects, LLC | 2001 | — |
| −3 | K122461 | Rhythmia Mapping Catheter | Rhythmia Medical, Inc. | 2013 | 1 |
| −2 | K143481 | IntellaMap Orion High Resolution Mapping Catheter | Rhythmia Medical, Inc. | 2015 | — |
| −1 | K192360 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2019 | — |
| 0 (this device) | K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | 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 NLG? 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 NLG device
- #1 K212776 Reprocessed Advisor HD Grid Mapping Catheter…score 4.3 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K192360 | IntellaMap Orion High Resolution Mapping CatheterSummary page 5…Product Code: NLG Predicate Device: 510(k) Number Device Manufacturer K192360 IntellaMap Orion High Resolution Mapping Boston Scientific Catheter… | 2019 |
| † | K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | 2020 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K192360.
How does its category compare?
All NLG devicesNLG Catheter, Intracardiac Mapping, High-Density, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NLG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NLG
Too few NLG 510(k)s in any year since 2007 to give a median.
Recalls per year · NLG
No recall names NLG since 2007.
Adverse event reports per year · NLG
2in 2025
MAUDE reports naming product code NLG, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211662: Reprocessed IntellaMap Orion High Resolution Mapping Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211662
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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