510(k) · Cleared
ClearedReprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
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 Dec 20, 2021 as substantially equivalent to K200212 (Innovative Health, LLC, 2020) and 1 other predicate after a 110-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Dec 20, 2021
- Review
- 110 days
- Class
- Class II
- Product code
- NLG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K983171 (1999). 18 ancestors in all, the oldest K961924 (1997). No later device cites it as a predicate yet.
- Root · 7 generations backK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999 · Recalled
- 6 generations backK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- 5 generations backK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- 4 generations backK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- 3 generations backK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- 2 generations backK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
- 1 generation backK200212 Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC · 2020
- This deviceK212776 Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | 1 |
| −6 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| −5 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| −4 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| −3 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| −2 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
| −1 | K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2020 | — |
| 0 (this device) | K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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 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 K211662 Reprocessed IntellaMap Orion High Resolution…score 3.3 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledSummary page 5…220 Product Code: NLG Predicate Device: 510(k) Number Device Manufacturer K200212 Reprocessed Advisor HD Grid Mapping Innovative Health, LLC. Catheter, Sens… | 2020 |
| * | K172393 | Advisor HD Grid Mapping Catheter, Sensor EnabledSummary page 5…urer K200212 Reprocessed Advisor HD Grid Mapping Innovative Health, LLC. Catheter, Sensor Enabled K172393 Advisor HD Grid Mapping Catheter, Sensor St. Jude Medical Enabled Refer… | 2018 |
| † | K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | 2018 |
| † | K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | 2019 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 18 ancestors have a recall of any class.
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 Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212776: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212776
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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