510(k) · Cleared
ClearedReprocessed Polaris X Steerable Diagnostic EP 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 May 10, 2016 as substantially equivalent to K003452 (Ep Technologies, Inc., 2000) and 1 other predicate after a 96-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- May 10, 2016
- Review
- 96 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924163 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924163 Explorer/360-Polaris-L.E./Jackman Coron Sinus ElecBoston Scientific Corp · 1993 · Recalled
- This deviceK160303 Reprocessed Polaris X Steerable Diagnostic EP CatheterInnovative Health, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924163 | Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec | Boston Scientific Corp | 1993 | 1 |
| 0 (this device) | K160303 | Reprocessed Polaris X Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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 |
|---|---|---|---|
| * | K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DSummary page 5…Product Code: NLH Predicate Device: 510(k) Number 510(k) Title Manufacturer K003452 Polaris X Catheters EP Technologies, Inc. K924163 Explorer/360-Polar… | 2000 |
| * | K924163 | Explorer/360-Polaris-L.E./Jackman Coron Sinus ElecSummary page 5…510(k) Title Manufacturer K003452 Polaris X Catheters EP Technologies, Inc. K924163 Explorer/360-Polaris-L.E./Jackman Boston Scientific, Corp. /Coron Sinus El… | 1993 |
| † | K052414 | Reprocessed Electrophysiology Catheter | 2005 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K003452.
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 Polaris X Steerable Diagnostic EP Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160303: Reprocessed Polaris X Steerable Diagnostic EP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160303
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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