510(k) · Cleared
ClearedReprocesses Umbilical Cable
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 Aug 6, 2022 as substantially equivalent to K193263 (Innovative Health, LLC, 2020) after a 40-day review. Its family tree reaches back 3 generations to 2011.
- Decided
- Aug 6, 2022
- Review
- 40 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K102588 (2011). No later device cites it as a predicate yet.
- Root · 3 generations backK102588 Achieve Mapping Catheter and Electrical CableMedtronic Ablation Frontiers, LLC · 2011 · Recalled
- 2 generations backK153139 Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. · 2016
- 1 generation backK193263 Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC · 2020
- This deviceK221854 Reprocesses Umbilical CableInnovative Health, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K102588 | Achieve Mapping Catheter and Electrical Cable | Medtronic Ablation Frontiers, LLC | 2011 | 1 |
| −2 | K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | Medtronic, Inc. | 2016 | — |
| −1 | K193263 | Reprocessed Achieve Catheter Connecting Cable | Innovative Health, LLC | 2020 | — |
| 0 (this device) | K221854 | Reprocesses Umbilical Cable | Innovative Health, LLC | 2022 | — |
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 |
|---|---|---|---|
| * | K193263 | Reprocessed Achieve Catheter Connecting CableSummary page 5…220 Product Code: NLH Predicate Device: 510(k) Number 510(k) Device Manufacturer K193263 Reprocessed Achieve Catheter Innovative Health, LLC. Connecting Cable… | 2020 |
| † | K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | 2021 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.
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/K221854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221854: Reprocesses Umbilical Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221854
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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