510(k) · Cleared
Recalled · Class II · 2015Achieve Mapping Catheter and Electrical Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Ablation Frontiers, LLC · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Mar 18, 2011 after a 190-day review. The FDA summary names its predicate without a number. 1 of the 12 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2011
- Review
- 190 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- This deviceK102588 Achieve Mapping Catheter and Electrical CableMedtronic Ablation Frontiers, LLC · 2011
- Descendant · cites it directly · 10 of its ownK153139 Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK162892 Achieve Advance Mapping CatheterMedtronic, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK223824 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™…Boston Scientific Corporation · 2023 · Recalled (Class I)
- Descendant · 4 generations on · 2 of its ownK233248 FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK193263 Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223824 POLARSHEATH™ Steerable Sheath 12F…3 generations on · 2023
Most influential descendants
Showing 5 of 11 · See all- K153139Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. · 2016 · cites it directly10descendants
- K162892Achieve Advance Mapping CatheterMedtronic, Inc. · 2016 · 2 generations on6descendants
- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation · 2023 · 3 generations on3descendants
- K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · 4 generations on2descendants
- K193263Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102588 | Achieve Mapping Catheter and Electrical Cable | Medtronic Ablation Frontiers, LLC | 2011 | — |
| +1 | K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | Medtronic, Inc. | 2016 | — |
| +2 | K162892 | Achieve Advance Mapping Catheter | Medtronic, Inc. | 2016 | — |
| +3 | K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular… | Boston Scientific Corporation | 2023 | Class I |
| +4 | K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023 | 3 |
| +2 | K193263 | Reprocessed Achieve Catheter Connecting Cable | Innovative Health, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | — | ProMap Catheter Named without a submission number | |
| * | — | LASSO Catheter Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | 2016 | 10 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2015 | Class II | Z-0200-2016 | Under Investigation by firm | 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K153139 (Medtronic, Inc., 2016) has gone furthest, with 10 descendants of its own.
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. 2011, 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 Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Mapper Catheter is designed to obtain electrograms in the atrial regions of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102588: Achieve Mapping Catheter and Electrical Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102588
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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