510(k) · Cleared
ClearedReprocessed Response 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 Dec 8, 2016 as substantially equivalent to K002976 (St Jude Medical, 2000) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Dec 8, 2016
- Review
- 156 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894500 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK894500 Daig Electrophysiology CatheterDaig Corp. · 1989 · Recalled
- This deviceK161827 Reprocessed Response Diagnostic Electrophysiology CathetersInnovative Health, LLC · 2016
- Descendant · cites it directly · 0 of its ownK182488 Reprocessed Response Diagnostic Electrophysiology CatheterInnovative Health, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K182488Reprocessed Response Diagnostic Electrophysiology CatheterInnovative Health, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894500 | Daig Electrophysiology Catheter | Daig Corp. | 1989 | 1 |
| 0 (this device) | K161827 | Reprocessed Response Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2016 | — |
| +1 | K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K002976 | Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX…Summary page 5…Product Code: NLH Predicate Device: 510(k) Number 510(k) Device Manufacturer K002976 Response Electrophysiology Catheter, St. Jude Medical, Daig Supreme Electrophy… | 2000 |
| * | K894500 | Daig Electrophysiology CatheterSummary page 5…Response Electrophysiology Catheter, St. Jude Medical, Daig Supreme Electrophysiology Catheter Division K894500 Daig Electrophysiology Catheter Daig Corp. Device Description: The Reprocessed Response… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | 2019 | 0 |
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?
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 Response Diagnostic Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
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/K161827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161827: Reprocessed Response Diagnostic Electrophysiology Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161827
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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