510(k) · Cleared
ClearedReprocessed Reflexion Spiral Bi-Directional Variable Radius 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 Oct 30, 2019 as substantially equivalent to K072012 (St Jude Medical, 2007) after a 182-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Oct 30, 2019
- Review
- 182 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961924 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
- 3 generations backK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
- 2 generations backK062251 Reflexion Spiral Variable Radius Catheter, Model 402804St Jude Medical · 2006
- 1 generation backK072012 Reflexion Spiral Variable Radius CatheterSt Jude Medical · 2007
- This deviceK191170 Reprocessed Reflexion Spiral Bi-Directional Variable Radius…Innovative Health, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961924 | Ibi-1100 Steerable Electrophysiology Catheter System | Irvine Biomedical, Inc. | 1997 | 2 |
| −3 | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable… | Irvine Biomedical, Inc. | 2004 | — |
| −2 | K062251 | Reflexion Spiral Variable Radius Catheter, Model 402804 | St Jude Medical | 2006 | — |
| −1 | K072012 | Reflexion Spiral Variable Radius Catheter | St Jude Medical | 2007 | — |
| 0 (this device) | K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology… | Innovative Health, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K072012 | Reflexion Spiral Variable Radius CatheterSummary page 5…0 Product Code: NLH Predicate Device: 510(k) Number 510(k) Title Manufacturer K072012 Reflexion Spiral Variable Radius Catheter St. Jude Medical Device Description: The Reprocess… | 2007 |
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 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K072012.
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 Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial 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/K191170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191170: Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191170
Report an extraction error
Are you the manufacturer?
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