510(k) · Cleared
ClearedReprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Dec 11, 2019 as substantially equivalent to K162892 (Medtronic, Inc., 2016) after a 149-day review. Its family tree reaches back 3 generations to 2011.
- Decided
- Dec 11, 2019
- Review
- 149 days
- Class
- Class II
- Product code
- DRF
- 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 backK162892 Achieve Advance Mapping CatheterMedtronic, Inc. · 2016
- This deviceK191880 Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology…Innovative Health, LLC · 2019
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 | K162892 | Achieve Advance Mapping Catheter | Medtronic, Inc. | 2016 | — |
| 0 (this device) | K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019 | — |
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 DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 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 |
|---|---|---|---|
| * | K162892 | Achieve Advance Mapping CatheterSummary page 5…Product Code: NLH Predicate Device: 510(k) Number 510(k) Device Manufacturer K162892 Achieve Advance Mapping Medtronic Electrophysiology Catheter… | 2016 |
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 8 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K162892.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in 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/K191880 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191880: Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191880
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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